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

Tracking Information
First Received Date ^ICMJE	March 9, 2005
Last Updated Date	June 23, 2005
Start Date ^ICMJE	April 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Plasma P-selectin level Aggregometry Serum thromboxane B2 Urinary Tx-M Urinary prostaglandin I2 (PGI-M)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00105209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Adverse events
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
Official Title ^ICMJE	A Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
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.
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).
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Hypertension, Pulmonary
Intervention ^ICMJE	Drug: Aspirin Drug: clopidogrel
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	December 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00105209
Other Study ID Numbers ^ICMJE	HL67771-01, RR00645, RR00095, RR15534
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Kawut, Steven, MD
Collaborators ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI) Columbia University
Investigators ^ICMJE
Information Provided By	Kawut, Steven, MD
Verification Date	March 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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