A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension - Full Text View

Sponsors and Collaborators:	Kawut, Steven, MD National Heart, Lung, and Blood Institute (NHLBI) Columbia University
Information provided by:	Kawut, Steven, MD
ClinicalTrials.gov Identifier:	NCT00105209

Purpose

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	Intervention	Phase
Hypertension, Pulmonary	Drug: Aspirin Drug: clopidogrel	Phase II

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension

Further study details as provided by Kawut, Steven, MD:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Adverse events

Estimated Enrollment:	20
Study Start Date:	April 2002
Estimated Study Completion Date:	December 2003

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105209

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

Study ID Numbers:	HL67771-01, RR00645, RR00095, RR15534
Study First Received:	March 9, 2005
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00105209
Health Authority:	United States: Institutional Review Board

Keywords provided by Kawut, Steven, MD:

Platelets

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Aspirin
Respiratory Tract Diseases
Hypertension, Pulmonary

Clopidogrel
Lung Diseases
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009