Dabigatran Versus Warfarin With NVAF Who Undergo PCI

Phase 4 Unknown 1120 enrolled Shenyang Northern Hospital Beijing Anzhen Hospital · collab Second Affiliated Hospital of Third Military Medical University · collab

RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start: 2018-09-01
Primary completion: 2019-12-31
Completion: 2020-06-30

Outcome

Missed primary endpoint

paper the dabigatran-based TAT regimen did not significantly reduce the rate of BARC types 2-5 bleeding at 6 months compared with warfarin-based regimen PMID 41254594 ↗

Publications

Liang M, Jin J, Zhao R, Li H, Chen S, Liu L, Xu P, Wang W, Cheng X, Chen X, Tao L, Zhang Q, Yang M, Zeng C, Li L, Zheng Y, Chen H, Guo J, Zhong Z, Bi Y, Cheng B, Zhou Y, Wang H, Zhang Y, Qiu M, Zhang Q, Zhang P, Zhang J, Wang Z, Li Y, Han Y. Dabigatran-based versus warfarin-based triple antithrombotic regimen with a 1-month intensification after coronary stenting in patients with nonvalvular atrial fibrillation (COACH-AF PCI). BMC Med. 2025 Nov 18;23(1):643. doi: 10.1186/s12916-025-04477-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dabigatran	Unknown	110 mg	—
Comparator	Warfarin	Small molecule	—	—
Background	Aspirin	Small molecule	100 mg	—
Background	Clopidogrel	Small molecule	75 mg	—