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

NCT ID: NCT00105209

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-12-31

Brief Summary

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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

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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).

Conditions

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Hypertension, Pulmonary

Keywords

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Platelets

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Aspirin

Intervention Type DRUG

clopidogrel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Kawut, Steven, MD

INDIV

Sponsor Role lead

Locations

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Columbia University College of Physicians and Surgeons

New York, New York, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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RR00645

Identifier Type: -

Identifier Source: secondary_id

RR00095

Identifier Type: -

Identifier Source: secondary_id

RR15534

Identifier Type: -

Identifier Source: secondary_id

HL67771-01

Identifier Type: -

Identifier Source: org_study_id