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

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Information provided by:
Kawut, Steven, MD
ClinicalTrials.gov Identifier:
First received: March 9, 2005
Last updated: June 23, 2005
Last verified: March 2005

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

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).

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00105209

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

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

Keywords provided by Kawut, Steven, MD:

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Sensory System Agents

ClinicalTrials.gov processed this record on May 26, 2016