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 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:

Genetics Home Reference related topics: pulmonary arterial hypertension

Drug Information available for: Aspirin Clopidogrel bisulfate

Genetic and Rare Diseases Information Center resources: Pulmonary Arterial Hypertension

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 (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

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


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

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

ClinicalTrials.gov processed this record on August 16, 2017

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