Status:
COMPLETED
A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
Lead Sponsor:
Kawut, Steven, MD
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Rationale: Idiopathic pulmonary arterial hypertension (IPAH) is characterized by in situ thrombosis and increased thromboxane A2 (Tx-M) synthesis. While both may be attributable to abnormal platelet f...
Detailed Description
This is a randomized, double-blind, placebo-controlled crossover study of aspirin 81 mg once daily and clopidogrel 75 mg once daily. Platelet function is assessed with plasma P-selectin levels and agg...
Eligibility Criteria
Inclusion
- Diagnosis of IPAH
- ≥ 18 years of age
- NYHA functional class I, II, or III
- Clinical stability (i.e., without change in pulmonary arterial hypertension medical regimen within one month prior to enrollment).
Exclusion
- Other forms of PAH
- A contraindication to ASA or clopidogrel
- Thrombocytopenia (defined as platelet count ≤ 75,000)
- History of intracranial hemorrhage or chronic thromboembolic disease
- Renal failure
- Inability or unwillingness to avoid non-steroidal anti-inflammatory agents, ASA, or warfarin use for the duration of the trial
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00105209
Start Date
April 1 2002
End Date
December 1 2003
Last Update
June 24 2005
Active Locations (2)
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1
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232