Status:
UNKNOWN
Optimal Antithrombotic Therapy for ACS Patients Concomitant With AF and Implanted With New-generation DES (OPTIMA-3, 4)
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Acute Coronary Syndrome (ACS)
Non-valvular Atrial Fibrillation (NVAF)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
It is a multi-center randomized clinical trial (RCT) which will enroll 3746 patients with acute coronary syndrome (ACS) concomitant non-valvular atrial fibrillation (NVAF) and undergoing new generatio...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
February 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
3746 Patients enrolled
Trial Details
Trial ID
NCT03234114
Start Date
February 3 2018
End Date
December 31 2024
Last Update
April 24 2023
Active Locations (1)
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1
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029