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

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Information provided by:
Kawut, Steven, MD
ClinicalTrials.gov Identifier:
NCT00105209
First received: March 9, 2005
Last updated: June 23, 2005
Last verified: March 2005
History of Changes
  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 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:

U.S. FDA Resources

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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:
Platelets

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Clopidogrel
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
 Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015