Impact of Dabigatran and Phenprocoumon on Clopidogrel Mediated ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation

NCT01352702 | Terminated Phase 4

• 2 other identifiers: GE IDE No. A017112011-000504-18
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate whether dabigatran reduces clopidogrel mediated ADP induced platelet aggregation measured by MEA as compared to phenprocoumon after a two-week treatment with either agent.

Conditions

Coronary Heart Disease; Atrial Fibrillation; Acute Coronary Syndrome; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• ADP induced platelet aggregation

  To determine whether there are differences in ADP induced platelet aggregation after 2 weeks in patients receiving dabigatran or phenprocoumon.

  2 weeks

Secondary Outcomes (2)

• Platelet function tests

  2 weeks

• Coagulation parameters

  2 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Dabigatran Therapy

Drug: Dabigatran

Arm 2

ACTIVE COMPARATOR

Phenprocoumon Therapy

Drug: Phenprocoumon

Interventions

Dabigatran DRUG

Patients assigned to this group will receive Dabigatran

Also known as: Pradaxa

Arm 1

Phenprocoumon DRUG

Patients assigned to this group will receive Phenprocoumon

Also known as: Marcumar

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with atrial fibrillation and an indication for oral anticoagulation (CHA2DS2-VASc score≥ 1).
• Current clopidogrel treatment
• Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.

You may not qualify if:

• Age ≤18 years
• Cardiogenic shock
• Current therapy with dabigatran
• Patients with a recent thromboembolic event and high thromboembolic risk requiring bridging therapy with either unfractionated heparin or LMWH
• Contraindication for oral anticoagulation
• Active bleeding
• Known allergy or intolerance to the study medications: dabigatran, phenprocoumon

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

MeSH Terms

Conditions

Coronary Disease; Atrial Fibrillation; Acute Coronary Syndrome; Atherosclerosis

Interventions

Dabigatran; Phenprocoumon

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Officials

• Julinda Mehilli, MD

  Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 12, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 5, 2015

Record last verified: 2015-02

Locations

DE (1)