NCT03536611

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,120

participants targeted

Target at P75+ for phase_4 atrial-fibrillation

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

April 25, 2018

Last Update Submit

January 3, 2019

Conditions

Atrial FibrillationCoronary Artery Disease

Keywords

dabigatranwarfarinnon-valve atrial fibrillationpercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • clinically relevant bleeding

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

    24 months

Secondary Outcomes (1)

  • Time to the first occurrence of major cardiovascular and cerebrovascular adverse events

    24 months

Other Outcomes (1)

  • other events

    24 months

Study Arms (2)

dabigatran

EXPERIMENTAL

dabigatran etexilate 110 mg bid + aspirin 100 mg qd + clopidogrel 75 mg qd for 1 month followed by dabigatran 110mg bid + clopidogrel 75mg/d for at least 5 months

Drug: dabigatran

warfarin

ACTIVE COMPARATOR

warfarin (according to clinical routine monitoring of INR, maintain the therapeutic range at 2.0-3.0) + aspirin 100 mg qd + clopidogrel 75 mg qd for 1 month followed by warfarin + clopidogrel 75mg/d for at least 5 months

Drug: warfarin

Interventions

dabigatranDRUG

dabigatran etexilate 110 mg bid + aspirin 100 mg qd + clopidogrel 75 mg qd for 1 month followed by dabigatran 110mg bid + clopidogrel 75mg/d for at least 5 months

dabigatran
warfarinDRUG

warfarin (according to clinical routine monitoring of INR, maintain the therapeutic range at 2.0-3.0) + aspirin 100 mg qd + clopidogrel 75 mg qd for 1 month followed by warfarin + clopidogrel 75mg/d for at least 5 months

warfarin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥18 years;
  • Patients with non-secondary (e.g., pericarditis, hyperthyroidism, recent surgery, etc.) nonvalvular atrial fibrillation requiring long-term anticoagulant treatment;
  • Patients who have PCI indications and coronary heart disease that was successfully treated with drug-eluting stenting (DES);
  • Patients who sign the informed consent form. -

You may not qualify if:

  • Patients with mechanical or biological heart valve prosthesis;
  • Patients proposed to undergo left atrial appendage occlusion or atrial fibrillation radiofrequency ablation
  • Cardiogenic shock during current hospitalization;
  • Patients who have used fibrinolytic agents within 24 hours of randomization that, in the opinion of the Investigator, will put the patient at high risk of bleeding;
  • Stroke within 1 month prior to screening visit;
  • Patients, who in the opinion of the Investigator, have had major surgery within the month prior to screening;
  • Patient has received an organ transplant or is on a waiting list for an organ transplant;
  • History of intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired (e.g. by surgery);
  • Gastrointestinal (GI) haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g. by surgery);
  • Major bleeding episode (reduction in the haemoglobin level of at least 2 g/dL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ) including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the haemoglobin level of at least 5 g/dL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) in one month prior to screening visit;
  • Haemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, haemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery/intervention);
  • Anaemia (haemoglobin \<10 g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count \<100×109/L) at screening (Visit 1);
  • Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation) \<30 mL/min at screening;
  • Active liver disease as indicated by at least one of the following:
  • Prior and persistent alanine aminotransferase (ALT) or Aspartate transaminase (AST) or alkaline phosphatase (AP) \>3 upper limit of normal (ULN);
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41254594DERIVED

MeSH Terms

Conditions

Atrial FibrillationCoronary Artery Disease

Interventions

DabigatranWarfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring4-HydroxycoumarinsCoumarinsBenzopyransPyrans

Study Officials

  • zulu Wang, PhD

    The General Hospital of Northern Theater Command

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Liang, PhD

CONTACT

17790991573lming000919@sina.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, clinical professor

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 24, 2018

Study Start

September 1, 2018

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

CN(1)