Outcomes of 1-month vs 3-month dual antiplatelet therapy in high bleeding risk patients after percutaneous coronary intervention, a randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20211024003

Enrollment

502

Registered

2021-10-24

Start date

2021-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study is a single-centre, randomized controlled trial, designed to compare the safety of 1-month and 3-month dual antiplatelet therapy in high bleeding risk patients after percutaneous coronary intervention from March 2021 to December 2021 at Maharaj Nakorn Chiang Mai hospital. The population will consist of subjects with acute coronary syndrome undergoing stent implantation. Subjects who fulfill the inclusion criteria will be randomly allocated in a 1:1 fashion to the treatment with 1-mont

Interventions

Subjects who fulfill the inclusion criteria will be randomly allocated in a 1:1 fashion to the treatment with 1-month or 3-month DAPT. The patients who were allocated for experimental arm (DAPT 1-mon

Experimental Drug,No Intervention Drug

DAPT 1-month,DAPT 3-month

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Thailand

Contacts

Public Contactpannipa suwannasom

Faculty of Medicine, Chiang Mai University

pannipa_100@hotmail.com053935486

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026