Dabigatran Versus Warfarin With NVAF Who Undergo PCI

Status Recruiting

Clinical Trial Summary

This study is to compare the efficacy and safety of dabigatran ethidium b.i.d.+ clopidogrel + ASA [100 mg q.d. *1 month] and warfarin + clopidogrel + ASA [100 mg, q.d.*1 month] in Chinese NVAF patients undergoing PCI with stenting (elective or due to ACS).

Clinical Trial Description

This is an open-label, multi-center, randomized, controlled, prospective study.The object of this study is to compare the safety and efficacy of dabigatran etexilate combined with dual anti-platelet therapy versus warfarin combined with dual anti-platelet therapy in Chinese patients with nonvalvular atrial fibrillation who undergo percutaneous coronary intervention.

The subjects are randomized into study group and control group using central randomization for open-label dosing:(1) Study group: dabigatran etexilate 110 mg bid + aspirin 100 mg qd + clopidogrel 75 mg qd. Aspirin is withdrawn 1 month later;(2) Control group: warfarin (according to clinical routine monitoring of INR, maintain the therapeutic rang at 2.0-3.0) + aspirin 100 mg qd + clopidogrel 75 mg qd. Aspirin is withdrawn 1 month later;All patients should receive the study medication for 6 month.

Primary endpoint:Time to the first occurrence of BARC-defined (grade 2-5) clinically relevant bleeding.

Key secondary endpoint:Time to the first occurrence of net clinical adverse events. Net clinical adverse event is composed of major cardiovascular and cerebrovascular adverse events (all death, recurrent myocardial infarction, ischemia-induced revascularization of the target vessel, or stroke/systemic embolism) or BARC-defined (grade 2-5) clinically relevant bleeding.

Secondary endpoints:1) Major cardiovascular and cerebrovascular adverse events 2) Major bleeding or clinically relevant non-major bleeding (ISTH definition) 3) Major bleeding (ISTH definition) 4) Any bleeding event (BARC-defined grade 1-5) 5) Clinically relevant bleeding (BARC-defined grade 2-5) 6) Bleeding (BARC-defined grade 3-5) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03536611
Study type	Interventional
Source	Shenyang Northern Hospital
Contact	Ming Liang, PhD
Phone	17790991573
Email	lming000919@sina.com
Status	Recruiting
Phase	Phase 4
Start date	September 1, 2018
Completion date	June 30, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Dabigatran Versus Warfarin With NVAF Who Undergo PCI — COACH-AF-PCI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms