Optimal Antithrombotic Therapy for ACS Patients Concomitant With AF and Implanted With New-generation DES (OPTIMA-3, 4)
Acute Coronary Syndrome (ACS), Non-valvular Atrial Fibrillation (NVAF)
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome (ACS) focused on measuring new generation drug eluting stent (DES), antithrombotic therapy, randomized clinical trial (RCT)
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years;
- ACS patients concomitant non-valvular AF (paroxysmal, persistent and permanent) underwent PCI and new-generation DES implantation;
- CHA2DS2-VASc score ≥ 2;
- Acceptable risk of bleeding at the discretion of the researchers (e.g. HAS-BLED score ≤ 2)
- Consent to participate in the trial
Exclusion Criteria:
- DES implanted in the left main coronary artery
- Cardiogenic shock or Killip III-IV
- STEMI patients with malignant arrhythmias or underwent electrodefibrillation or CPR or with cardiac mechanical complications (heart rupture, ventricular septal perforation, nipple muscle fracture, etc.)
- History of gastrointestinal or intracranial hemorrhage; active bleeding, trauma or major surgery within one month; suspected or diagnosed aortic dissection
- Ischemic stroke with limb dysfunction or dysphasia
- Known allergy or intolerance to the study medications: warfarin, clopidogrel, aspirin, dabigatran, ticagrelor and heparin
- Participating in other ongoing trials
- Planned surgery in 12 months requiring to withdraw the antiplatelet agents
- Planned RFCA or left atrial appendage occlusion in the next 12m
- Abnormal liver or kidney function (ALT ≥ 3 ULN; estimated CrCl < 30 ml/min calculated by Cockcroft-Gault equation); diagnosed liver cirrhosis
- Hematological disease with bleeding tendency; hemoglobin < 100 g/L, platelet count < 100 × 10^9 /L
- Malignancies or life expectancy less than 1 year
- Pregnant (present, suspected, or planned) or lactating woman
- Patients who are taking drugs which may interact with study agents, such as miconazole, ketoconazole, fluconazole, voriconazole, itraconazole, posaconazole, efinaconazole, and rifampicin, etc.
- Patients with any other conditions that may not be suitable to participate in the trial at the discretion of the researchers.
Sites / Locations
- First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
1-month TAT
6-month TAT
12-month DAT-1
12-month DAT-2
Randomized experimental group in the OPTIMA-3 substudy; Triple antithrombotic therapy (warfarin with targeted INR 2.0-3.0, clopidogrel 75 mg q.d. and aspirin 100 mg q.d.) for 1 month (30 days) then quit aspirin till 12 months after PCI
Randomized control group in the OPTIMA-3 substudy; Triple antithrombotic therapy (warfarin with targeted INR 2.0-3.0, clopidogrel 75 mg q.d. and aspirin 100 mg q.d.) for 6 months (180 days)then quit aspirin till 12 months after PCI
Randomized experimental group in the OPTIMA-4 substudy; Dual antithrombotic therapy including dabigatran 110 mg b.i.d. with clopidogrel 75 mg q.d. for 12 months after PCI
Randomized control group in the OPTIMA-4 substudy; Dual antithrombotic therapy including dabigatran 110 mg b.i.d. with ticagrelor 90 mg b.i.d for 12 months after PCI