Skip to content

A Randomized Controlled Study on the Second - level Prevention of Dabigatran and Warfarin in Atrial Fibrillation Associated Ischemic Stroke / TIA Acute Phase

A Randomized Controlled Study on the Second - level Prevention of Dabigatran and Warfarin in Atrial Fibrillation Associated Ischemic Stroke / TIA Acute Phase

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011973
Enrollment
Unknown
Registered
2017-07-13
Start date
2017-07-20
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

Atrial fibrillation ischemic stroke Atrial fibrillation associated transient ischemic attack

Interventions

Dabigatran Etexilate 110mg group:Dabigatran Etexilate 110mg
Warfarin INR ratio (1.5-3.0) group:Warfarin 1-3mg

Sponsors

The Department of Neurology, The Second Affiliated Clinical Hospital Of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged greater than 18 years old; 2. New York Heart Association (NYHA) heart function classification> = 2; 3. systolic blood pressure <180mmHg, or diastolic blood pressure <100mmHg; 4. Paroxysmal, persistent, permanent nonvalvular atrial fibrillation; 5. Acute ischemic stroke within 14 days; 6. If CHA2DS2-VASc score = 2 points; 7. Signed informed consent; Choose better compliance patients, in order to complete test and observation.

Exclusion criteria

Exclusion criteria: 1. Heart valve disease atrial fibrillation or heart valve disease after valve surgery; ; 2. Liver dysfunction, liver cirrhosis decompensated or active liver disease and liver enzymes increased = 2ULN (normal upper limit), renal dysfunction (CrCL <30mL / min); 3. Hemorrhagic disease or bleeding quality: such as thrombocytopenia or screening of thrombocytopenia <100 * 103 or coagulation disorders associated with bleeding tendency to disease, such as hemophilia, etc .; 4. There is a history of non-traumatic bleeding in the posterior or intra-articular or intra-articular area, with intracranial aneurysms ; 5. One months of major surgery history, 3 months history of cerebral hemorrhage, 6 months of history of gastrointestinal bleeding (etiology to permanent removal or repair excluded), confirmed by gastrointestinal ulcer (1 month before the endoscopy Confirmed that healed except); 6. Patients with cerebral infarction after the onset of bleeding, such as the group before screening head CT or head MRI showed bleeding such as cerebral hemorrhage, lower hemorrhage, epidural hemorrhage, dural hematoma, cerebral hemorrhage after the conversion; 7. Clinical bleeding may be possible, such as this fracture, brain trauma, digestive tract ulcers or screening before the occult blood potential; 8. Patients with malignant tumors or currently undergoing radiotherapy and chemotherapy are expected to have a life expectancy of less than 3 months due to disease causes; 9. Within 24 hours after intravenous thrombolysis; 10. The disease needs to use low molecular weight heparin treatment, the disease needs to be combined with antiplatelet therapy, the disease needs long-term use of non-steroidal anti-inflammatory drugs (NSAID) patients; 11. We are currently using active P-gp inhibitors and P-gp patients (eg cyclosporine, ketoconazole, itraconazole, tacrolimus and dronedarone); 12. Due to difficulty swallowing, can not oral dabigatran capsules; 13. Has been pregnant or intended to be pregnant during the course of the study.

Design outcomes

Primary

MeasureTime frame
The HAS-BLED score;MRS score;CHA2DS2-VASc score;CHA2DS2 score;The BI score;NIHSS score;Bleeding events evaluation;The finish event evaluation;

Countries

China

Contacts

Public ContactFu Jin

The Department of Neurology, The Second Affiliated Clinical Hospital Of Harbin Medical University

fujin6677@126.com+86 13039998769

Outcome results

None listed

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