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

Phase 2

Completed

• Conditions: Hypertension, Pulmonary

• Registration Number: NCT00105209
• Lead Sponsor: Kawut, Steven, MD

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 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.

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 aggregometry after exposure to adenosine diphosphate, arachidonic acid, and collagen. We will assess serum levels of thromboxane B2 and urinary metabolites of thromboxane A2 and prostaglandin I2 (Tx-M and PGI-M, respectively).

Study Timeline

• Study Start: 2002-04
• Study Completion: 2003-12
• Status Verified: 2005-03
• Study First Submitted: 2005-03-09
• Study First Submitted QC: 2005-03-09
• Study First Posted: 2005-03-10
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Plasma P-selectin level
Aggregometry
Serum thromboxane B2
Urinary Tx-M
Urinary prostaglandin I2 (PGI-M)

Secondary Outcome Measures

Name	Time	Method
Adverse events

Trial Locations

Locations (2)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Columbia University College of Physicians and Surgeons; 🇺🇸 New York, New York, United States