Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy

NCT01852162 | Completed Results DMC

• 1 other identifier: UFJ 2011-112
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of treatment for prevention of atherothrombotic events in patients with coronary artery disease (CAD) undergoing percutaneous coronary interventions (PCI). Many patients on dual antiplatelet therapy in this setting may be affected by other thromboembolic conditions, in particular atrial fibrillation, therefore having an indication to also receive oral anticoagulation for stroke prevention. Thus, a considerable percentage of patients are under "triple therapy" which consists of aspirin plus clopidogrel plus an oral anticoagulant. The ever raising population with CAD warranting triple therapy and the growing number of patients being treated with dabigatran underscores the importance of understanding the pharmacodynamic effects of this treatment regimen.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; antiplatelet therapy; anticoagulant therapy

Outcome Measures

Primary Outcomes (1)

• TRAP-induced Platelet Aggregation

  TRAP-induced platelet aggregation measured by light transmittance aggregometry (LTA) was similar between groups

  1 week

Secondary Outcomes (4)

• Platelet Reactivity Measured by LTA

  1-week

• Platelet Reactivity Measured by Multiple Electrode Aggregometry.

  1-week

• Clot Kinetic: Thrombin Activity

  1-week

• Clot Kinetic: Clot Stength

  1-week

Study Arms (2)

Dabigatran

EXPERIMENTAL

Dabigatran 150mg

Drug: Dabigatran

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Dabigatran DRUG

Dabigatran 150mg

Also known as: Pradaxa

Dabigatran

Placebo DRUG

Matching placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known CAD
• On maintenance treatment with aspirin (81 to 325mg per day) and clopidogrel (75 mg per day) for at least for at least 4-weeks as per standard of care.
• Age between 18 and 80 years old.

You may not qualify if:

• Transient ischemic attack or ischemic stroke in the past 6 months.
• Prior hemorrhagic stroke (irrespective of timing).
• Known allergies to dabigatran.
• On treatment with Coumadin derivate or have an indication to be on Coumadin treatment (atrial fibrillation, prosthetic valve, DVT/pulmonary embolism).
• Platelet count \<80x106/mL
• Active bleeding or hemodynamic instability.
• Creatinine clearance \<30 mL/minute.
• Baseline ALT \>2.5 times the upper limit of normal.
• Hemoglobin \< 10 gm/dL
• Pregnant females\*. \*Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dominick Angiolillo, MD, PhD
• Organization: University of Florida

dominick.angiolillo@jax.ufl.edu

904-244-3933

Study Officials

• Dominick Angiolillo, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 13, 2013
• Study Start: February 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 17, 2015
• Results First Posted: March 17, 2015

Record last verified: 2015-03

Locations

US (1)