Key result
The OPTIMA-4 trial is an ongoing randomized study designed to evaluate whether clopidogrel is comparable in efficacy and superior in safety to ticagrelor when combined with dabigatran.
Why the study?
The optimal antithrombotic regimen remains uncertain for acute coronary syndrome patients with concomitant atrial fibrillation requiring both antiplatelet and anticoagulant therapies after stent implantation.
Does clopidogrel compared to ticagrelor (both combined with dabigatran) reduce bleeding without compromising efficacy in ACS patients with NVAF after DES implantation?
RCT (n=1,472)
randomly assigned
Yes
Does clopidogrel compared to ticagrelor (both combined with dabigatran) reduce bleeding without compromising efficacy in ACS patients with NVAF after DES implantation?
The OPTIMA-4 trial is designed to evaluate the optimal P2Y12 inhibitor (clopidogrel vs ticagrelor) combined with dabigatran in patients with ACS and atrial fibrillation undergoing PCI.
Choice of P2Y12 inhibitor with dabigatran post-PCI remains uncertain in ACS with NVAF; OPTIMA-4 will deliver the first RCT comparison.
BACKGROUND: About 5%-15% of acute coronary syndrome (ACS) patients undergoing stent implantation have concomitant atrial fibrillation and need both antiplatelet and anticoagulant therapies. The optimal antithrombotic regimen remains uncertain in this scenario. HYPOTHESIS: A multicenter randomized controlled trial (OPtimal management of anTIthroMbotic Agents [OPTIMA]-4) is designed to test the hypothesis that, for ACS patients with concomitant nonvalvular atrial fibrillation (NVAF) and having low-to-moderate risk of bleeding, clopidogrel is comparable in efficacy but superior in safety compared to ticagrelor while being used in combination with dabigatran after new-generation drug-eluting stent (DES) implantation. METHODS: -VASc score ≥ 2) will be recruited after implantation of new-generation DES. A total of 1472 eligible patients will be randomly assigned to receive a 12-month dual antithrombotic treatment of either clopidogrel 75 mg daily or ticagrelor 90 mg twice daily in combination with dabigatran 110 mg twice daily. Participants will be followed up for 12 months after randomization. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction, unplanned revascularization, ischemic stroke, and systemic thromboembolism. The primary safety endpoint is set as major bleeding or clinically relevant nonmajor bleeding defined by the International Society of Thrombosis and Hemostasis. The enrollment and follow-up have been launched. RESULTS: The first enrollment occurred on March 12, 2018. The recruitment is anticipated to be completed before December 31, 2024. CONCLUSIONS: The OPTIMA-4 trial offers an opportunity to assess the optimal dual antithrombotic regimen in ACS patients with concomitant NVAF after the implantation of new-generation DES.
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Gong et al. (2023) conducted an RCT in Acute coronary syndrome with concomitant nonvalvular atrial fibrillation (n=1,472). Clopidogrel plus dabigatran vs. Ticagrelor 90 mg twice daily plus dabigatran 110 mg twice daily was evaluated on Composite of cardiovascular death, myocardial infarction, unplanned revascularization, ischemic stroke, and systemic thromboembolism. The OPTIMA-4 trial is an ongoing randomized study designed to evaluate whether clopidogrel is comparable in efficacy and superior in safety to ticagrelor when combined with dabigatran.
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