Overview

A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension

Status:
Completed
Trial end date:
2003-12-01
Target enrollment:
0
Participant gender:
All
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 function, there are no studies of anti-platelet therapy in IPAH. Objectives: The purpose of this study is to assess the effects of aspirin (ASA) and clopidogrel on platelet function and eicosanoid metabolism in patients with IPAH.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kawut, Steven, MD
Collaborators:
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Aspirin
Clopidogrel
Ticlopidine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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