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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00105209
Recruitment Status : Completed
First Posted : March 10, 2005
Last Update Posted : June 24, 2005
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Information provided by:
Kawut, Steven, MD

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).

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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

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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00105209

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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

Layout table for additonal information Identifier: NCT00105209    
Other Study ID Numbers: HL67771-01
First Posted: March 10, 2005    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2005
Keywords provided by Kawut, Steven, MD:
Additional relevant MeSH terms:
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Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Neurotransmitter Agents