Outcomes of 1-month vs 3-month dual antiplatelet therapy in high bleeding risk patients after percutaneous coronary intervention, a randomized controlled trial
- Registration Number
- TCTR20211024003
- Lead Sponsor
- Faculty of Medicine, Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 502
1.All subjects age more than 18 years of age
2.diagnosis of acute coronary syndrome (STEMI or NSTEMI) who are acceptable candidates for treatment with a DES.
3.The subjects must meet pre-defined ARC-HBR criteria for being high-bleeding risk and are candidates for 1-month DAPT. Patients are considered to be at HBR if at least 1 major or 2 minor criteria are met
1.Pregnant and breastfeeding women
2.Atrial fibrillation
3.Subjects requiring a planned PCI procedure after 1 month of index procedure
4.Procedure planned to require stand-alone POBA, or stand-alone atherectomy
5.Active bleeding at the time of inclusion
6.Cardiogenic shock
7.Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
8.Subject not expected to comply with long-term single antiplatelet therapy.
9.A known hypersensitivity or contraindication to aspirin, heparin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings, stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre- medicated.
10.PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
11.Participation in another clinical study within 12 months after index procedure
12.Subjects with life expectancy of less than 2 years
13.History of stent thrombosis on. Antiplatelet treatment
14.History of bifurcation stenting with two-stent technique, stenting of last patent vessel
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method composite EP CD MI ST 1 year Composite endpoints of cardiac death, myocardial infarction, definite or probable stent thrombosis and BARC type 3 or 5 at 1 year
- Secondary Outcome Measures
Name Time Method cardiac death 1 year cardiac death,MI 1 year MI,definite or probable stent thrombosis 1 year definite or probable stent thrombosis ,BARC type 3 or 5 1 year BARC type 3 or 5