Clopidogrel Treatment Group Research Articles

Comparison of ticagrelor and clopidogrel in anemic patients with acute coronary syndrome: efficacy and safety outcomes over one year.

This retrospective study aimed to investigate the potential impact of ticagrelor and clopidogrel treatment on cardiovascular outcomes in patients with anemia and acute coronary syndrome (ACS) and to provide insights into the optimal therapeutic approach for this vulnerable patient population. A retrospective research design was employed, involving patients diagnosed with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) between 2014 and 2021. Inclusion criteria required a hemoglobin level below 12mg/dL and a minimum 12-month P2Y12 inhibitor treatment. Comprehensive clinical, biochemical, and echocardiographic data were collected from the hospital's electronic repository. The primary efficacy endpoint was major adverse cardiovascular events (MACE), encompassing total mortality, cardiovascular mortality, reinfarction, ischemic stroke, and hemorrhagic stroke. Major hemorrhage was the primary safety endpoint. Secondary outcomes included total mortality, cardiovascular mortality, reinfarction, ischemic stroke, and hemorrhagic stroke, individually. Patients treated with ticagrelor (n = 118) and clopidogrel (n = 538) were compared. No significant difference was observed in major adverse cardiovascular events (MACE) and major bleeding between ticagrelor and clopidogrel treatment groups (MACE: clopidogrel 10.0% vs. ticagrelor 11.0%, p = 0.75; major bleeding: clopidogrel 2.8%, ticagrelor 2.5%, p = 0.88). Patients with hemoglobin levels ≤ 8mg/dL demonstrated significantly higher MACE and major bleeding rates in the ticagrelor group (p = 0.008 and p = 0.002, respectively). Among patients aged ≥ 75 years, ticagrelor treatment was associated with a higher risk of major bleeding (p = 0.04). Ticagrelor and clopidogrel exhibited comparable efficacy and safety outcomes in anemic ACS patients over a one-year period. Although ticagrelor demonstrated superiority in reducing ischemic events, it is crucial to recognize the limitations of retrospective studies in informing clinical practice. This study offers valuable insights into tailoring antiplatelet therapy for anemic ACS patients and provides guidance for personalized treatment strategies, acknowledging the hypothesis-generating nature of retrospective analyses.

The Bleeding Safety of Ticagrelor in Patients With ST-Elevation Acute Coronary Syndrome Treated With Fibrinolytic Therapy

Aim To compare hemorrhagic safety of ticagrelor and clopidogrel in patients with ST-segment elevation acute coronary syndrome (STEACS) after thrombolytic therapy (TLT).Material and methods This nonrandomized study included 183 patients followed up for 30 days. Hemorrhagic safety was compared in a group of patients with STEACS (n=71) after a thrombolytic treatment with alteplase and early ticagrelor treatment (180 mg followed by switching to 90 mg twice daily) and in a group of patients (n=112) with STEACS receiving TLT with alteplase and clopidogrel (loading dose, 600 mg followed by switching to 75 mg daily). Primary endpoint was hemorrhage associated with TLT; patients were followed up for 30 days.Results During the follow-up period, TLT-associated hemorrhages were observed in 11.3% of patients in the ticagrelor treatment group and in 10.7% of patients in the clopidogrel treatment group (p=0.9; odds ratio, 1.06 at 95 % confidence interval, from 0.41 to 2.73). Intracranial hemorrhages and fatal hemorrhages were absent in both groups.Conclusion There were no significant differences in hemorrhagic safety between patients with STEACS after the TLT treatment with alteplase and early treatment with ticagrelor or clopidogrel.

The value of cytochrome P4502C19 gene assay for anti-platelet therapy after PCI in stable angina patients with left main coronary artery lesions

To evaluate the efficacy and safety of different antiplatelet therapies for stable angina patients with complicated left main coronary artery lesions and intermediate metabolizer Cytochrome P450 2C19 gene (CYP2C19) undergoing PCI. A total of 247 patients diagnosed with stable angina in cardiology department of Fujian union hospital from February 2015 to February 2017 were retrospectively analyzed, among them, the elective PCI were performed on the left main coronary artery and the CYP2C19 gene poly-morphism were intermediate metabolize, they were divided into ticagrelor treatment group(aspirin combined with ticagrelor, n=95)and clopidogrel treatment group(aspirin combined with clopidogrel, n=152) according to the different antiplatelet treatment programs. Both groups were given aspirin 300 mg and clopidogrel 300 mg orally before PCI; the ticagrelor group were given the maintenance dose of ticagrelor (90 mg orally, twice a day) after PCI, while those in clopidogrel group were clopidogrel 75 mg orally (once a day) after PCI; both groups were given the maintenance dose of aspirin (100 mg orally, once a day)after PCI. The major adverse cardiovascular events (MACE) were observed within 12 months after PCI. At 12 months after PCI, the incidence of MACE in the ticagrelor treatment group was significantly lower than that in the clopidogrel treatment group, the difference was statistically significant (2.1% vs 15.1%, P=0.001).There were no significant differences between the two groups in the restenosis rates of non- revascularized target vessel, recurrent rates of angina pectoris(but not myocardial infarction), recurrent rates of myocardial infarction, and revascularization rates of target vessel (P > 0.05). There were also no significant differences between the two groups in bleeding. For stable angina patients with complicated left main coronary artery lesions and intermediate metabolizer CYP2C19 gene, aspirin combined with ticagrelor antiplatelet therapy after PCI is effective, the effect of ticagrelor is better than clopidogrel on MACE, and ticagrelor does not seem to increase the risk of bleeding.

The therapeutic effect of Ilex pubescens extract on blood stasis model rats according to serum metabolomics

Ethnopharmacological relevanceIlex pubescens Hook. et Arn (MDQ), a traditional Chinese herb, is used in the treatment of cardiovascular diseases. However, the mechanisms underlying the preventive effect of MDQ on blood stasis remain unclear. Aim of the studyIn this study, serum metabolomics integrated with a biochemical assay strategy were established to evaluate the preventive effect and mechanism of action of MDQ on rats with acute blood stasis. Materials and methodsForty-nine rats were divided into seven groups: the control group, model group, aspirin treatment group (30 mg/kg), clopidogrel treatment group (8 mg/kg) and three MDQ treatment groups (250, 500 and 1000 mg/kg). A hybrid quadrupole time of flight mass spectrometry (QTOF/MS) coupled to ultra-high-performance liquid chromatography (UPLC) was applied for profiling the serum metabolites. The multivariate data analysis techniques using unsupervised principal component analysis (PCA) and supervised orthogonal projections to latent structures discriminant analysis (OPLS-DA) were used for pattern recognition and distinguishing variabilities among groups. ResultsMDQ protected the rats against blood stasis, as evidenced by the restoration of the anti-platelet aggregation activity, fibrinogen concentration, prothrombin time, thrombin time, activated partial thromboplastin time, endothelial nitric oxide synthase, endothelin, thromboxane B2 and 6-keto-prostaglandin F1α. The combination of PCA and OPLS-DA revealed deviations in eighteen differential biomarkers in serum. The identified biomarkers were primarily engaged in the metabolic pathways including arachidonic acid metabolism, glycerophospholipid metabolism, phospholipid biosynthesis and bile acid biosynthesis. The levels of eleven biomarkers showed significant alterations and a tendency to be restored to normal values in MDQ-treated blood stasis rats. Moreover, a correlation network diagram was constructed to show the serum biomarkers perturbed by MDQ. ConclusionsThese results suggested that MDQ had preventive effects on blood stasis in rats via arachidonic acid metabolism and glycerophospholipid metabolism.

Effects of Triflusal and Clopidogrel on the Secondary Prevention of Stroke Based on Cytochrome P450 2C19 Genotyping.

Background and Purpose To compare the efficacy and safety of antiplatelet agents for the secondary prevention of ischemic stroke based on cytochrome P450 2C19 (CYP2C19) polymorphisms. Methods This study was a prospective, multicenter, randomized, parallel-group, open-label, blind genotype trial. First time non-cardiogenic ischemic stroke patients were enrolled and screened within 30 days. Participants were randomized to receive either triflusal or clopidogrel for secondary stroke prevention. The primary outcome was the time from randomization to first recurrent ischemic stroke or hemorrhagic stroke. Results The required sample size was 1,080 but only 784 (73%) participants were recruited. In patients with a poor CYP2C19 genotype for clopidogrel metabolism (n=484), the risk of recurrent stroke among those who received triflusal treatment was 2.9% per year, which was not significantly different from those who received clopidogrel treatment (2.2% per year; hazard ratio [HR], 1.23; 95% confidence interval [CI], 0.60–2.53). In the clopidogrel treatment group (n=393), 38% had good genotypes and 62% poor genotypes for clopidogrel metabolism. The risk of recurrent stroke in patients with a good CYP2C19 genotype was 1.6% per year, which was not significantly different from those with a poor genotype (2.2% per year; HR, 0.69; 95% CI, 0.26–1.79). Conclusions Whilst there were no significant differences between the treatment groups in the rates of stroke recurrence, major vascular events, or coronary revascularization, the efficacy of antiplatelet agents for the secondary prevention of stroke according to CYP2C19 genotype status remains unclear.

Rationale and Design for a Randomized Comparison of Efficacy and Safety between Aspirin and Clopidogrel in Atrial Fibrillation Patients with Low Stroke Risk: CESAC-AF trial

BackgroundAtrial fibrillation (AF) increases the risk of thromboembolic stroke. An oral anticoagulant should be administrated to prevent stroke in patients with moderate stroke risk (ie, CHA2DS2-VASc score>2). If the stroke risk is low (i.e. the score=1), however, antiplatelet agent such as aspirin is widely used. Aspirin can cause peptic ulcer disease (PUD) while its alternative, clopidogrel, theoretically does not. ObjectiveTo elucidate the efficacy and safety between aspirin and clopidogrel, a multicenter randomized controlled trial was designed in AF patients with low stroke risk. MethodsAccording to sample size estimation based on previous literature, a total of 1560 AF patients with low stroke risk will be randomly assigned into 4 different groups dependent upon initial esophagogastroduodenoscopy (EGD) results: two mono-antiplatelet treatment groups with either aspirin 100mg or clopidogrel 75mg for 1year; two antiplatelet agent and proton pump inhibitor (PPI) combination groups. Follow-up EGD will be performed at 1year. ResultsThe clinical follow-up will be performed for 1year after enrollment. The primary efficacy endpoint is to compare the annual stroke rate between aspirin and clopidogrel treatment groups. The primary safety endpoint is to compare the prevalence of drug-induced gastrointestinal (GI) and intracranial hemorrhage and upper-GI response including PUD based on EGD after 1year. ConclusionsThis trial will determine whether clopidogrel is noninferior in stroke prevention and superior in reduction of GI events including PUD to aspirin in AF patients with low stroke risk. (ClinicalTrials.gov: NCT02960126).

Abstract TP411: Effects of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on Cytochrome P450 2C19 Genotyping

Background: The relationship between stroke recurrence and cytochrome P450 2C19 (CYP2C19) genotype for the secondary prevention of ischemic stroke (IS) is not clearly defined. We investigated the effect of antiplatelet agents based on CYP2C19 genotype in secondary prevention of IS. Methods: In this prospective, multicenter, randomized, parallel-group, open-label, and blind genotype trial, we enrolled first non-cardiogenic IS patients within 30 days prior to screening at the 18 tertiary-care hospitals. Participants received 300 mg triflusal twice a day or 75 mg clopidogrel once daily. CYP2C19 genotyping was done in all patients and genotype results were blind during the study. The primary outcome was the time from randomization to first recurrent IS or hemorrhagic stroke. Efficacy analyses were performed using both the modified intention-to- treat population and the per-protocol population. The study is registered with ClinicalTrials.gov (NCT01174693). Results: This trial failed to meet its recruitment goal due to slow enrollment. A total of 784 (73% of required sample size) patients were followed for a mean of 2.5 years. In poor CYP2C19 genotype group (n=484), 30 (6.2%) patients had a recurrent stroke. The risk of recurrent stroke in triflusal group was 2.9% per year and was not significantly different with clopidogrel group (2.2% per year; hazard ratio [HR], 1.23; 95% confidence interval [CI], 0.6 to 2.53). In clopidogrel treatment group (n=393), 20 (5.1%) had a recurrent stroke. The risk of recurrent stroke in good CYP2C19 genotype was 1.6% per year and was not significantly different with poor genotype (2.2% per year; HR, 0.69; 95% CI, 0.26 to 1.79). Conclusions: In poor CYP2C19 genotype group, either triflusal or clopidogrel was not superior to the other in the prevention of recurrent stroke.

硫酸氢氯吡格雷联合西洛他唑治疗糖尿病四肢并发症的临床疗效观察

Objective: To observe efficacy and safety of domestic clopidogrel cilostazol in treatment of diabetic limbs complications. Methods: 120 cases of diabetic patients with limb complications were randomly selected, including 60 cases of lower extremity arterial disease (PAD) and 60 patients with diabetic peripheral neuropathy (DPN) patients. According to the random number list, they were randomly divided into treatment group of 60 patients, DPN and PAD were given mecobalamin 0. 5mg / times , lipoic acid 500mg / d, alprostadil 10ug / d, DPN patients while giving epalrestat 50mg / times. The control group while giving cilostazol 0.1g, 2 times / d, plus clopidogrel treatment groups 150mg / d in the control group, based on continuous treatment for 8 weeks. Clinical evaluation of the two groups was made and conduction velocity of MNCV and SNCV was compared. R esults: Analysis of DPN subgroup showed that the treatment group was efficient (73.4% vs 46.7%, P = 0.035), total efficiency (93.3% vs 73.3%, P = 0.038) were significantly higher, PAD subgroup analysis showed the efficiency of the treatment group was (70% vs 43.3%, P = 0.035), total efficiency (93.3% vs 73.3%, P = 0.038) were significantly higher. MNCV CKS nerve (54.3 ± 4.8 vs 50.5 ± 5.1) and the peroneal nerve (34.7 ± 3.2 vs 30.9 ± 3.4) conduction velocity improved more significantly. SNCV CKS nerve (43.4 ± 4.9 vs 38.2 ± 3.8) and the peroneal nerve (35.1 ± 5.6 vs 32.9 ± 5.4) conduction velocity, the treatment group improved significantly than the control group. PAD subgroup analysis, ABI degree of improvement (0.9 ± 0.3 vs 0.8 ± 0.3), dorsal blood flow (35.2±3.6 vs31.5±4.2), popliteal artery blood flow (64.2±5.6 vs 58.4±7.4) were better than the control group. Compared with clopidogrel, cilostazol did not increase in adverse events during treatment process. Conclusion : Clopidogrel cilostazol treatment of diabetic limb complications becomes safe and effective treatment of DPN and PAD, which can be used as a combination therapy.

Economic Evaluation of Clopidogrel in Acute Coronary Syndrome Patients without ST-Segment Elevation in Greece

Current guidelines recommend treatment with antiplatelet and anticoagulant therapy for the secondary prevention of atherothrombotic events among patients with non-ST-segment elevation myocardial infarction (NSTEMI) or unstable angina (UA). The CURE (Clopidogrel in Unstable angina to prevent Recurrent Events) trial has shown that clopidogrel alone or in combination with aspirin is more effective in reducing the risk of atherothrombotic events than aspirin alone in NSTEMI or UA patients. However, in the current climate of financial constraints, the effectiveness of a treatment should be considered in conjunction with its long-term economic costs to determine the best possible care. To evaluate the cost effectiveness of 1 year of treatment with clopidogrel in addition to aspirin in NSTEMI or UA patients from the third-party-payer perspective in Greece. An existing Markov model consisting of six states (NSTEMI/UA/no event, first year with stroke, history of stroke, first year with myocardial infarction [MI], history of MI and death) was adapted and extended to the Greek healthcare setting for year 2012. Utility values obtained from a Greek national study were assigned to each health state in order to estimate the quality-adjusted life-years (QALYs). Costs assigned to each health state included antiplatelet treatment cost, cost for the management of adverse events and the costs for concomitant medication, hospitalization, outpatient visits, rehabilitation and nursing. Cost effectiveness and cost utility was expressed as the cost per life-year (LY) gained and QALY gained, respectively. A probabilistic sensitivity analysis was conducted. The Markov analysis predicts a discounted survival of 8.27 years in the aspirin treatment group and 8.41 years in the aspirin plus clopidogrel treatment group. The corresponding discounted QALYs were 6.88 and 7.00, respectively. The cumulated lifetime costs per patient were € 18 779 and € 19 191, for the aspirin and aspirin plus clopidogrel treatment arms, respectively. The incremental cost-effectiveness ratio (ICER) with the addition of clopidogrel was &U20AC;2951 for each LY saved and &U20AC;3541 for each QALY saved. Finally, clopidogrel plus aspirin was found to be cost effective in more than 95% of simulated samples at a threshold of &U20AC;7000 per discounted QALY gained. One-year treatment with clopidogrel in addition to aspirin is a cost-effective treatment option for secondary prevention in patients with acute coronary syndrome without ST-segment elevation in Greece.

Long-term cost-effectiveness of clopidogrel in patients with acute coronary syndrome without ST-segment elevation in Germany

Patients with acute coronary syndrome without ST-segment elevation receiving clopidogrel in addition to acetylsalicylic acid (ASA) showed a 20% risk reduction in comparison to patients receiving ASA monotherapy (CURE trial). Economic models for assessing the impact on costs exist for several countries but not for Germany on a long-term basis. The objective of this model adaptation is to assess the long-term economic impact of clopidogrel taken in addition to ASA in Germany. A Markov model with six states [at risk, first year with stroke, following years with stroke, first year with new myocardial infarction (MI), following years with MI, and death] was adapted for Germany. Model outcome was life-years saved. Effects of 1-year treatment were calculated based on the CURE trial. Resource use for the different health states was based on published data, which included costs for drugs, outpatient care, hospitalization, rehabilitation and nursing. Risk data for MI and stroke were based on Swedish data and validated for the German adaptation. The model calculates lifetime costs and survival length. Costs were estimated from the payers' perspective. A series of one-way sensitivity analyses was conducted (follow-up costs, discount rates). The Markov analysis predicts a survival of 8.89years in the placebo treatment group and 9.02 years in the clopidogrel treatment group. The cumulated costs were euro 8,548 and euro 8,953, respectively. The incremental cost-effectiveness ratio (ICER) was euro 3,113 for each life-year saved. The model was robust regarding variations in key parameters in the sensitivity analysis, resulting in a range of ICER from euro 1,338 to euro 9,322. Our results are in line with the results for other healthcare systems. Adding clopidogrel to ASA for patients with acute coronary syndrome without ST-segment elevation generated an additional life-year saved at a comparably low value of euro 3,113. One-year treatment with clopidogrel is a cost-effective treatment option in patients with acute coronary syndrome from the perspective of a third-party payer in Germany.

PCV5 LONG-TERM COST-EFFECTIVENESS OF CLOPIDOGREL® IN PATIENTS WITH ACUTE CORONARY SYNDROME WITHOUT ST-SEGMENT ELEVATION IN GERMANY

Patients with acute coronary syndrome without ST-segment elevation receiving clopidogrel in addition to acetylsalicylic acid (ASA) showed a 20% risk reduction in comparison to patients receiving ASA monotherapy (CURE trial). Economic models for assessing the impact on costs exist for several countries but not for Germany on a long-term basis. The objective of this model adaptation is to assess the long-term economic impact of clopidogrel taken in addition to ASA in Germany. A Markov model with six states [at risk, first year with stroke, following years with stroke, first year with new myocardial infarction (MI), following years with MI, and death] was adapted for Germany. Model outcome was life-years saved. Effects of 1-year treatment were calculated based on the CURE trial. Resource use for the different health states was based on published data, which included costs for drugs, outpatient care, hospitalization, rehabilitation and nursing. Risk data for MI and stroke were based on Swedish data and validated for the German adaptation. The model calculates lifetime costs and survival length. Costs were estimated from the payers’ perspective. A series of one-way sensitivity analyses was conducted (follow-up costs, discount rates). The Markov analysis predicts a survival of 8.89 years in the placebo treatment group and 9.02 years in the clopidogrel treatment group. The cumulated costs were €8,548 and €8,953, respectively. The incremental cost-effectiveness ratio (ICER) was €3,113 for each life-year saved. The model was robust regarding variations in key parameters in the sensitivity analysis, resulting in a range of ICER from €1,338 to €9,322. Our results are in line with the results for other healthcare systems. Adding clopidogrel to ASA for patients with acute coronary syndrome without ST-segment elevation generated an additional life-year saved at a comparably low value of €3,113. One-year treatment with clopidogrel is a cost-effective treatment option in patients with acute coronary syndrome from the perspective of a third-party payer in Germany.