Abstract
BackgroundDual antiplatelet therapy (DAPT) with aspirin (ASP) and a P2Y12 blocker is currently standard care after percutaneous coronary intervention (PCI) with stent insertion, and aims to inhibit platelet function in order to prevent stent thrombosis. The P2Y12 blocker ticagrelor (TIC) has greater antiplatelet effect than the previously used members of this class, such as clopidogrel. In healthy volunteers, TIC is sufficient to cause strong platelet inhibition, with little additional effect from ASP. Omission of ASP may improve the safety of antiplatelet regimes by reducing bleeding. However, the effect of single antiplatelet treatment with TIC, compared to DAPT with TIC + ASP, has not been studied in detail in patients with coronary artery disease.MethodsTo compare TIC with TIC + ASP, we have initiated a single centre, open-label randomised controlled trial (TEMPLATE study) in adults receiving DAPT following PCI with a sample size of 110 patients. Patients are invited to join the study when, as part of standard care, they are due to switch from DAPT (ASP + any P2Y12 blocker) to single antiplatelet treatment with ASP alone after 6–12 months. Patients are randomised to receive either TIC or TIC + ASP for 4 weeks. All patients then revert to standard care with ASP alone. Blood samples and clinical data are collected at three study visits: at baseline during treatment with ASP + any P2Y12 blocker (visit 1); approximately 4 weeks after visit 1 during treatment with either TIC or TIC + ASP (visit 2); and approximately 8 weeks after visit 1 when treatment has reverted to ASP alone (visit 3). The primary outcome is the extent of platelet inhibition, measured by light transmission aggregation, flow cytometry, flow chamber and plasma biomarker tests. The primary analysis will compare the extent of platelet inhibition between the TIC and TIC + ASP groups at visit 2, adjusted for baseline platelet reactivity. Secondary analyses will compare the extent of platelet inhibition at visit 2 with that at visit 3.DiscussionThis is the first study to compare in detail the extent of platelet inhibition in patients who are receiving TIC compared with TIC + ASP. The study findings will complement larger-scale trials of the clinical efficacy and safety of TIC compared to TIC + ASP.Trial registrationISRCTN registry, identifier ISRCTN84335288. Registered on 23 June 2014.
Highlights
Dual antiplatelet therapy (DAPT) with aspirin (ASP) and a P2Y12 blocker is currently standard care after percutaneous coronary intervention (PCI) with stent insertion, and aims to inhibit platelet function in order to prevent stent thrombosis
Dual antiplatelet therapy (DAPT) with aspirin (ASP) and a P2Y purinoreceptor (P2Y12) blocker is standard care for patients with coronary artery disease in several settings, including after acute coronary syndrome (ACS) and percutaneous coronary intervention (PCI) with or without coronary stent insertion [1,2,3]. The rationale for this treatment is that most adverse cardiac events that occur in these settings result from the formation of abnormal platelet aggregates causing coronary artery or stent thrombosis
Patients will be ineligible if any of the following apply: (i) contraindication to DAPT; (ii) treatment with ASP + any P2Y12 blocker after PCI was interrupted or terminated because of bleeding or increased bleeding risk; (iii) contraindication to TIC; (iv) pregnancy and or breast feeding; (v) the patient is a woman of childbearing potential who is unwilling to use contraception; (vi) the patient is a man with a spouse or partner with childbearing potential unless the patient is sterilised or has agreed to use barrier contraceptives
Summary
Study population The study population is patients at the BHI who have been prescribed DAPT as part of standard clinical care following PCI and coronary stent insertion. All patients will be transferred to ASP 75 mg once per day, thereby returning to standard clinical care This treatment will continue until study visit 3 which will be 28 days (acceptable range 21–35 days) after study visit 2, and thereafter, long-term. Actionable sign of haemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: requiring nonsurgical, medical intervention by a healthcare professional, leading to hospitalisation or increased level of care, prompting evaluation. The enrolment rate increased to that predicted in the original study design
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