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

Sponsor

Kawut, Steven, MD (Other)

Overall Status

Completed

CT.gov ID

NCT00105209

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Columbia University (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Pulmonary	Drug: Aspirin Drug: clopidogrel	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension

Study Start Date :

Apr 1, 2002

Study Completion Date :

Dec 1, 2003

Outcome Measures

Primary Outcome Measures

Plasma P-selectin level []
Aggregometry []
Serum thromboxane B2 []
Urinary Tx-M []
Urinary prostaglandin I2 (PGI-M) []

Secondary Outcome Measures

Adverse events []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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