Dabigatran Versus Warfarin After Mitral and/or Aortic Bioprosthesis Replacement and Atrial Fibrillation Postoperatively (DAWA)

September 14, 2015 updated by: Andre Duraes, PhD, Hospital Ana Nery

Dabigatran Versus Warfarin After Mitral and Aortic Bioprosthesis Replacement for the Management of Atrial Fibrillation Postoperatively: Pilot Study

DAWA is a phase 2, prospective, open-label, randomized, pilot study. The main variable to be observed in this study is intracardiac thrombus. There are no formal primary or secondary clinical efficacy or safety outcomes because it is a pilot study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Mortality and morbidity events (reversible ischemic neurological deficit, ischemic and hemorrhagic stroke, systemic embolism, any bleeding, prosthesis valve thrombosis and death) were evaluated in an exploratory manner. The details of the trial design have been previously described.8 The trial protocol was approved by the local ethics and research committee in the city of Salvador-Brazil, and written informed consent was obtained from all patients. An independent data and safety monitoring board closely monitored the trial. All the members contributed to the interpretation of the results, wrote the first version of the manuscript and approved all versions, made the decision to submit the manuscript for publication, and vouch for the accuracy and completeness of the data reported and the fidelity of this article to the study protocol.

Patients eligible for inclusion in the study were 18 to 64 years old, underwent mitral and/or aortic bioprosthesis valve replacement at least 3 months prior to entering the study and had documented AF postoperatively in addition to exclusion of atrial thrombus or valve prosthesis thrombosis by transesophageal echocardiography (TEE). Non-contrast brain computed tomography (CT) without hemorrhage or findings of acute cerebral infarction on the last 2 days of screening was also necessary.

Patients were randomly assigned to receive dabigatran or warfarin by a computer generated list of random numbers performed to 1:1 ratio between the groups. Following that, the allocation sequence was concealed from the researcher enrolling participants in sequentially numbered, opaque, black, sealed envelopes. After randomization, patients had study visits scheduled at 7 days (via telephone) and at 30 days (personally) with a monthly follow-up for 90 days. After this, non-contrast brain CT and TEE were repeated. The former was executed to document possible cerebral events with no clinical expression and the latter to analyze the incidence of intracardiac thrombi, new dense spontaneous echo contrast (SEC) or its resolution, in addition to thrombosis or dysfunction of valvular prosthesis.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40320010
        • Hospital Ana Nery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age from 18 to 64 years at entry
  2. Patients with mitral and/or aorthic valve bioprosthesis for at least 3 months postoperatively
  3. There is 12-lead electrocardiogram documented AF on the day of screening or randomization; or a 24-hour Holter electrocardiogram recording showing AF episodes postoperatively
  4. Brain computed tomography scan without hemorrhage or findings of acute cerebral infarction on the last 2 days of screening
  5. Exclusion of atrial thrombus or valve prosthesis thrombosis by transesophageal echocardiograph on the last 2 days of screening
  6. Written, informed consent

Exclusion Criteria:

  1. Previous hemorrhagic stroke
  2. Ischemic stroke in the last 6 months
  3. Severe renal impairment (creatinine clearance rates < 30 ml/min)
  4. Active liver disease (any etiology)
  5. Concomitant use of any antiplatelet (aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine, etc)
  6. Increased risk of bleeding (congenital or acquired)
  7. Uncontrolled hypertension
  8. Gastrointestinal hemorrhage within the past year
  9. Anemia (hemoglobin level <10 g/dL) or thrombocytopenia (platelet count < 100 × 109/L)
  10. Active infective endocarditis
  11. Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dabigatran
Dabigatran 110 mg BID
Drug: Dabigatran
Group 1 - Dabigatran 110 mg (50 patients)
Other Names:
  • Pradaxa® (dabigatran etexilate) 110mg twice daily
Active Comparator: Warfarin
Warfarin adjusted-dose
Drug: Warfarin
Warfarin adjusted-dose
Other Names:
  • Warfarin adjusted-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracardiac Thrombus
Time Frame: 90 days
The primary endpoint was the detection of intracardiac thrombus in TEE at the end of follow-up (90 days).
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spontaneous Echo Contrast
Time Frame: 90 days
Spontaneous Echo Contrast showed in Transesophageal echocardiography
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Ana Nery

Investigators

  • Principal Investigator: Andre R Duraes, Professor, Hospital Ana Nery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAWA2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Disease

Clinical Trials on Dabigatran

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe