Mono- Versus Dual antiPlatelet Therapy During 6-12 Months After New Generation Drug Eluting Stent Implantation

• Status: Recruiting
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: All

Summary

Long-term DAPT is recommended after percutaneous coronary intervention (PCI) in patients with coronary artery disease. However, antiplatelet therapy may have adverse consequences, the most common of which is gastrointestinal mucosal injury with ulceration and bleeding. The extent to which an an abbreviated DAPT strategy reduces gastrointestinal mucosal injury has not been studied, principally due to the lack of sensitive, noninvasive measurements capable of detecting gastrointestinal injury.ANKON® magnetically controlled capsule endoscopy (AMCE) is a non-invasive, active controlled system which affords assessment of the stomach and entire small intestine.The current randomized study will assess gastrointestinal mucosal injury and bleeding via AMCE in patients on three different antiplatelet regimens and establish a gastrointestinal mucosal injury scoring system which may prove useful in guiding optimal antiplatelet agent usage after PCI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenyang Northern Hospital
• Collaborators: ANKON medical technologies (Shanghai)Co.,LTD; Changhai Hospital
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

1. Adult patients with age of 18-80 years;

2. Presentation with silent ischemia, stable angina, or non-ST-segment elevation acute coronary syndrome with GRACE score <140 on admission;

3. 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)].

4. PCI resulted in complete revascularization (successful PCI treatment of all epicardial coronary lesions with diameter stenosis >70% or intermediate lesions with FFR ≤0.80);

5. Intended treatment with dual antiplatelet therapy (aspirin + clopidogrel) after the DES procedure for at least 6 months;

6. Agreement to comply with all study procedures.

7. Written informed consent provided.

Exclusion Criteria:

1. Presentation with STEMI;

2. Left main disease (diameter stenosis >30% );

3. Any prior coronary stent implantation during the last year prior to the index procedure;

4. Implantation of of first-generation drug-eluting stents or bioabsorbable scaffolds during the index procedure;

5. Implantation of >4 stents during the index procedure;

6. Any prior stent thrombosis;

7. Any active gastrointestinal bleeding or ulcers, or prior gastrointestinal bleeding or ulcers within the last 24 months;

8. 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;

9. 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)

10. Severe hemorrhoids (phase 3-4 according to guidelines of American Society of Colon and Rectal Surgery);

11. LVEF <0.40 on admission according to cardiac ultrasound;

12. Renal dysfunction (eGFR <30ml/min/1.73m2);

13. Active hepatitis or ALT >3 times upper limits of normal on admission;

14. Uncontrolled severe hypertension (>180/110mmHg);

15. Hemoglobin <100 g/L;

16. Platelet count <100×109/L;

17. Planned use of a proton pump inhibitor, gastric mucosa protectant or any other antacid agent after study enrollment；

18. Required use of oral anticoagulation (warfarin or other factor II or factor X inhibitors);

19. Inability to take 12-month DAPT for any reason;

20. Mandatory use of >6 month DAPT (i.e. contraindication to aspirin or clopidogrel monotherapy after 6 months);

21. Any comorbidity with estimated survival time <12 months (e.g. progressive cancer, chronic obstructive lung disease, etc.);

22. Any contraindication to MRI examination, including implantation of an MRI-incompatible pacemaker, defibrillator, or other ferromagnetic material; etc.

23. Pregnant or plan to be pregnant within 1 year;

24. Any condition that may interfere with any study procedures, such as dementia, immobility, alcohol use, etc.;

25. Planned surgery within 1 year;

26. Taking iron supplement;

27. Participating in any other clinical trial of an investigational drug or device that has not met its primary endpoint.