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dabigatran versus warfarin for intracardiac thrombus (mainly left atrial appendage thrombus) in patients with nonvalvular atrial fibrillation or atrial flutter

dabigatran versus warfarin for intracardiac thrombus (mainly left atrial appendage thrombus) in patients with nonvalvular atrial fibrillation or atrial flutter

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003739
Enrollment
Unknown
Registered
2013-10-27
Start date
2013-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

atrial fibrillation/atrial flutter

Interventions

Sponsors

Qilu Hospital, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. older than 18; 2. intracardiac thrombus, mainly in left atrial appendage detected by Echocardiography; 3. ECG or Holter based atrial fibrillation/atrial flutter; 4. Echocardiography shows hemodynamic stable non-valvular atrial fibrillation or atrial flutter;

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to the active substance or to any of the excipients; 2. Patients with severe renal impairment (CrCL less than 30 mL/min); 3. Active clinically significant bleeding; 4. Lesion or condition, if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; 5. Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under the circumstances of switching therapy to or from Pradaxa or when UFH is given at doses necessaryto maintain an open central venous or arterial catheter; 6. Hepatic impairment or liver disease expected to have any impact on survival; 7. Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole, tacrolimus and dronedarone; 8. mechanical heart valves requiring anticoagulant treatment.

Design outcomes

Primary

MeasureTime frame
coagulation indicator;Echocardiography;blood routine examination;

Countries

China

Contacts

Public ContactJingquan Zhong

Qilu Hospital, Shandong University

gilman_zhong@hotmail.com+86 13791123056

Outcome results

None listed

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