A randomized controlled trial of indobufen versus aspirin plus dabigatran after stable coronary artery disease in atrial fibrillation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000029015

Enrollment

Unknown

Registered

2020-01-11

Start date

2020-02-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

Coronary artery disease

Interventions

Indobufen:Indobufen 200mg bid for 6 monh

Control:Aspirin 100mg qd, and Dabigatran 110mg bid for 6 months

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years. 2. Stable coronary artery disease including at least 1 branch of coronary artery stenosis of more than 50% without the need of PCI and had the hsitory of PCI or CABG for more than 1 year. 3. Atrial fibrillation was recorded for at least 1 time by electrocardiogram or 24h dynamic electrocardiogram monitoring. 4. CHA2DS2-VAS score >= 2. 5. Participants volunteer to participate in the study with written informed consent form signed.

Exclusion criteria

Exclusion criteria: 1. With a history of myocardial infarction or stroke; 2. With a history of intracranial hemorrhage at anytime or with gastrointestinal hemorrhage within 6 months; 3. With a schedule of interventional revascularization in 1 month; 4. With a history of severe heart failure or vavular disease; 5. With coagulation disorders or with blood platelet less than 100 x 10^9/L; 6. With reversible atrial fibrillation of specific secondary causes (eg.hyperthyroidism); 7. With uncontroled hypertension(SBP >= 180mmHg or DBP >= 120mmHg); 8. Allergic to NSAID or dabigatran; 9. With serious hepatic or renal insufficiency (ALT >= 1.5 x ULN,AST >= 1.5 x ULN or Cr >1.5 x ULN); 10. Pregnant, lactating or preparing for conception; 11. Life expectancy is less than 12 months; 12. Subjects who participate in other interventional clinical trials at the same time.

Design outcomes

Primary

Measure	Time frame
treadmill exercise testing(load);Serum D-dimer test;Serious bleeding event;All-cause mortality;	—

Secondary

Measure	Time frame
Serum coagulation;Cardiovascular events;	—

Countries

China

Contacts

Public ContactXiangqing Kong

The First Affiliated Hospital of Nanjing Medical University

kongxq@njmu.edu.cn+86 13951610265

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026