Atrial FibrillationPhase 4COACH-AF-PCINCT03536611
Dabigatran Versus Warfarin With NVAF Who Undergo PCI
A Phase 4 study testing dabigatran and warfarin in people with Atrial Fibrillation and Coronary Artery Disease, run by Shenyang Northern Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Disease
- What is being tested?
- dabigatran and warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- 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;
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- 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);
- Known active hepatitis C; ③Known active hepatitis B; ④Known active hepatitis A;
- Recent malignancy or radiation therapy (≤6 months) unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months;
- Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, or any cytotoxic/myelosuppressive therapy;
- Patients who, in the Investigator's opinion, need continuous treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
- Patients with a known allergy to dabigatran etexilate or to the excipients used for the capsule of the drug
- Patients with a known allergy to warfarin tablets or to the excipients
- Patients who, in the Investigator's opinion, should not be treated with OAC;
- Patients with a contraindication to clopidogrel, or ASA
- Pre-menopausal women (last menstruation ≤1 year prior to screening) who experienced any of the following conditions:
- Are pregnant or breast feeding; ②Are pregnant surgically sterile; ③Are of child bearing potential and not practising two acceptable methods of birth control, or do not plan to continue practising an acceptable method of birth control throughout the trial. (Acceptable methods of birth control are oral or parenteral (patch, injection, implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication, intrauterine device or intrauterine system, double-barrier method of contraception (condom and occlusive cap or condom and spermicidal agent), male sterilization and complete sexual abstinence (if acceptable by local authorities)). Periodic abstinence is not an acceptable method of contraception.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
Ming Liang
About this study
Official title: A Randomized Study Comparing Dabigatran Etexilate Versus Warfarin in Chinese Patients With Nonvalvular Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention With Stenting (DES)
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).
Read the detailed 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)
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Being tested
- dabigatran, warfarin
- Keywords
- dabigatran, warfarin, non-valve atrial fibrillation, percutaneous coronary intervention
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinically relevant bleeding
Time to the first occurrence of BARC-defined (grade 2-5) clinically relevant bleeding.
Measured: 24 months
Secondary outcomes (1)
Time to the first occurrence of major cardiovascular and cerebrovascular adverse events
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Second Affiliated Hospital of Third Military Medical University
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
- Investigators
- zulu Wang, PhD, Principal investigator, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536611
- Sponsor's protocol ID
- SYNH-K201813
- Acronym
- COACH-AF-PCI
- Status last verified
- Jan 2019
- First submitted
- 25 Apr 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 41254594
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing Dabigatran Etexilate Versus Warfarin in Chinese Patients With Nonvalvular Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention With Stenting (DES)
- ClinicalTrials.gov ID
- NCT03536611
- Acronym / sponsor ID
- COACH-AF-PCI / SYNH-K201813
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Keywords
- dabigatran, warfarin, non-valve atrial fibrillation, percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,120 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Second Affiliated Hospital of Third Military Medical University
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dabigatran | Experimental | Drug: dabigatrandabigatran 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 |
| warfarin | Active comparator | Drug: warfarinwarfarin (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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. -
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dabigatrandabigatran 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 |
| warfarinwarfarin (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 |
Primary outcome
clinically relevant bleeding
Time frame: 24 months
Time to the first occurrence of BARC-defined (grade 2-5) clinically relevant bleeding.
1 secondary outcome
Time to the first occurrence of major cardiovascular and cerebrovascular adverse events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Derived from this study: PubMed 41254594Liang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zulu Wang, PhD principal investigator
The General Hospital of Northern Theater Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dabigatran and warfarin in people with Atrial Fibrillation and Coronary Artery Disease, run by Shenyang Northern Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Liang, PhD (17790991573, lming000919@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinically relevant bleeding (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03536611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.