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

Kawut, Steven, MD20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension, Pulmonary

Interventions

AspirinDRUG

clopidogrelDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Columbia University College of Physicians and Surgeons

New York, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Plasma P-selectin level

Aggregometry

Serum thromboxane B2

Urinary Tx-M

Urinary prostaglandin I2 (PGI-M)

Secondary Outcomes

Adverse events

Data from ClinicalTrials.gov

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