Mono- Versus Dual antiPlatelet Therapy During 6-12 Months After New Generation Drug Eluting Stent Implantation (OPT-PEACE)
Gastrointestinal Injury, Ischemic Heart Disease
About this trial
This is an interventional treatment trial for Gastrointestinal Injury
Eligibility Criteria
Inclusion Criteria:
- Adult patients with age of 18-80 years;
- Presentation with silent ischemia, stable angina, or non-ST-segment elevation acute coronary syndrome with GRACE score <140 on admission;
- PCI only with implantation of current generation drug-eluting stent(s) for coronary artery disease during the present admission [current generation DES refers to DES with thin cobalt-chromium or platinum-chromium struts, with a durable or biodegradable polymer eluting a rapamycin-analogue antiproliferative agent. The current major DES available in China market include: EXCEL and EXCEL 2 (JW Medical System, Weihai, China), Tivoli(Essen Technology, Beijing, China), Endeavor Resolute (Medtronic Inc., Minnesota, USA), FireHawk (MicroPort Medical (Group) Co., Ltd, Shanghai, China), BuMA (SinoMedical,China),Xience V (Abbott Laboratories, Abbott Park, Illinois, USA), Xience Prime (Abbott Laboratories, Abbott Park, Illinois, USA), Promus Element and Synergy (BostonTechnologies, Massachusetts, USA)].
- PCI resulted in complete revascularization (successful PCI treatment of all epicardial coronary lesions with diameter stenosis >70% or intermediate lesions with FFR ≤0.80);
- Intended treatment with dual antiplatelet therapy (aspirin + clopidogrel) after the DES procedure for at least 6 months;
- Agreement to comply with all study procedures.
- Written informed consent provided.
Exclusion Criteria:
- Presentation with STEMI;
- Left main disease (diameter stenosis >30% );
- Any prior coronary stent implantation during the last year prior to the index procedure;
- Implantation of of first-generation drug-eluting stents or bioabsorbable scaffolds during the index procedure;
- Implantation of >4 stents during the index procedure;
- Any prior stent thrombosis;
- Any active gastrointestinal bleeding or ulcers, or prior gastrointestinal bleeding or ulcers within the last 24 months;
- Prior gastrointestinal tract or abdominal surgery other than simple procedures which would not change the gastrointestinal tract anatomy, such as polyp removal, cholecystectomy or appendectomy;
- Contraindications to the AMCE test, including suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, etc.; presence of gastrointestinal obstruction symptoms such as pain or dysphagia; inoperative conditions or refusal to undergo abdominal surgery if required (i.e, if the capsule will not pass and cannot be removed by endoscopy)
- Severe hemorrhoids (phase 3-4 according to guidelines of American Society of Colon and Rectal Surgery);
- LVEF <0.40 on admission according to cardiac ultrasound;
- Renal dysfunction (eGFR <30ml/min/1.73m2);
- Active hepatitis or ALT >3 times upper limits of normal on admission;
- Uncontrolled severe hypertension (>180/110mmHg);
- Hemoglobin <100 g/L;
- Platelet count <100×109/L;
- Planned use of a proton pump inhibitor, gastric mucosa protectant or any other antacid agent after study enrollment;
- Required use of oral anticoagulation (warfarin or other factor II or factor X inhibitors);
- Inability to take 12-month DAPT for any reason;
- Mandatory use of >6 month DAPT (i.e. contraindication to aspirin or clopidogrel monotherapy after 6 months);
- Any comorbidity with estimated survival time <12 months (e.g. progressive cancer, chronic obstructive lung disease, etc.);
- Any contraindication to MRI examination, including implantation of an MRI-incompatible pacemaker, defibrillator, or other ferromagnetic material; etc.
- Pregnant or plan to be pregnant within 1 year;
- Any condition that may interfere with any study procedures, such as dementia, immobility, alcohol use, etc.;
- Planned surgery within 1 year;
- Taking iron supplement;
- Participating in any other clinical trial of an investigational drug or device that has not met its primary endpoint.
Sites / Locations
- General Hospital of Shenyang Military Region
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Aspirin+clopidogrel
Aspirin
Clopidogrel
Open label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),continue aspirin + clopidogrel (12-month DAPT group).The treatments between 6 and 12 months are double-blinded. Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks).
Open label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),receive aspirin + placebo (aspirin monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded. Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks).
Open label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),receive clopidogrel + placebo (clopidogrel monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded. Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks).