NCT01868243

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 9, 2015

Completed
Last Updated

October 9, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

May 28, 2013

Results QC Date

June 24, 2015

Last Update Submit

September 14, 2015

Conditions

Primary Disease

Keywords

Atrial FibrillationBioprosthesisStrokeDabigatranWarfarin

Outcome Measures

Primary Outcomes (1)

  • Intracardiac Thrombus

    The primary endpoint was the detection of intracardiac thrombus in TEE at the end of follow-up (90 days).

    90 days

Secondary Outcomes (1)

  • Spontaneous Echo Contrast

    90 days

Study Arms (2)

Dabigatran

EXPERIMENTAL

Dabigatran 110 mg BID

Drug: Dabigatran

Warfarin

ACTIVE COMPARATOR

Warfarin adjusted-dose

Drug: Warfarin

Interventions

DabigatranDRUG

Group 1 - Dabigatran 110 mg (50 patients)

Also known as: Pradaxa® (dabigatran etexilate) 110mg twice daily
Dabigatran
WarfarinDRUG

Warfarin adjusted-dose

Also known as: Warfarin adjusted-dose
Warfarin

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 18 to 64 years at entry
  • Patients with mitral and/or aorthic valve bioprosthesis for at least 3 months postoperatively
  • 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
  • Brain computed tomography scan without hemorrhage or findings of acute cerebral infarction on the last 2 days of screening
  • Written, informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Ana Nery

Salvador, Estado de Bahia, 40320010, Brazil

Location

Related Publications (7)

  • Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.

    PMID: 16980116BACKGROUND

  • Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005 Nov;5(11):685-94. doi: 10.1016/S1473-3099(05)70267-X.

    PMID: 16253886BACKGROUND

  • Sun JC, Davidson MJ, Lamy A, Eikelboom JW. Antithrombotic management of patients with prosthetic heart valves: current evidence and future trends. Lancet. 2009 Aug 15;374(9689):565-76. doi: 10.1016/S0140-6736(09)60780-7.

    PMID: 19683642BACKGROUND

  • Heras M, Chesebro JH, Fuster V, Penny WJ, Grill DE, Bailey KR, Danielson GK, Orszulak TA, Pluth JR, Puga FJ, et al. High risk of thromboemboli early after bioprosthetic cardiac valve replacement. J Am Coll Cardiol. 1995 Apr;25(5):1111-9. doi: 10.1016/0735-1097(94)00563-6.

    PMID: 7897124BACKGROUND

  • Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30.

    PMID: 19717844BACKGROUND

  • Duraes AR, de Souza Roriz P, de Almeida Nunes B, Albuquerque FP, de Bulhoes FV, de Souza Fernandes AM, Aras R. Dabigatran Versus Warfarin After Bioprosthesis Valve Replacement for the Management of Atrial Fibrillation Postoperatively: DAWA Pilot Study. Drugs R D. 2016 Jun;16(2):149-54. doi: 10.1007/s40268-016-0124-1.

    PMID: 26892845DERIVED

  • Duraes AR, Roriz PD, Bulhoes FV, Nunes BD, Muniz JQ, Neto IN, Fernandes AM, Reis FJ, Camara EJ, Junior ED, Segundo DTs, Silva FP, Aras R. Dabigatran versus warfarin after bioprosthesis valve replacement for the management of atrial fibrillation postoperatively: protocol. JMIR Res Protoc. 2014 Apr 1;3(2):e21. doi: 10.2196/resprot.3014.

    PMID: 24691436DERIVED

MeSH Terms

Conditions

Atrial FibrillationStroke

Interventions

DabigatranWarfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring4-HydroxycoumarinsCoumarinsBenzopyransPyrans

Results Point of Contact

Title
Andre Rodrigues Duraes
Organization
Hospital Ana Nery
andreduraes@gmail.com
+557191888399

Study Officials

  • Andre R Duraes, Professor

    Hospital Ana Nery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Andre Rodrigues Duraes

Study Record Dates

First Submitted

May 28, 2013

First Posted

June 4, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

October 9, 2015

Results First Posted

October 9, 2015

Record last verified: 2015-09

Locations

BR(1)