A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
Information source: Kawut, Steven, MD
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension, Pulmonary
Intervention: Aspirin (Drug); clopidogrel (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Kawut, Steven, MD
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.
Clinical Details
Official title: A Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Plasma P-selectin levelAggregometry Serum thromboxane B2 Urinary Tx-M Urinary prostaglandin I2 (PGI-M)
Secondary outcome: Adverse events
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Columbia University College of Physicians and Surgeons, New York, New York 10032, United States
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States
Additional Information
Starting date: April 2002
Last updated: June 23, 2005
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