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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Type :	Interventional (Clinical Trial)
Enrollment :	20 participants
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 :	April 2002
Study Completion Date :	December 2003

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Plasma P-selectin level
2. Aggregometry
3. Serum thromboxane B2
4. Urinary Tx-M
5. Urinary prostaglandin I2 (PGI-M)

Secondary Outcome Measures :

1. Adverse events

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Kawut, Steven, MD

National Heart, Lung, and Blood Institute (NHLBI)

Columbia University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00105209 History of Changes
Other Study ID Numbers:	HL67771-01; RR00645; RR00095; RR15534
First Posted:	March 10, 2005
Last Update Posted:	June 24, 2005
Last Verified:	March 2005

Keywords provided by Kawut, Steven, MD:

Platelets

Additional relevant MeSH terms:

Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Aspirin; Ticlopidine; Clopidogrel; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents

Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents