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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00105209 |
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Date of registration:
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09/03/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
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Scientific title:
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A Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension |
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Date of first enrolment:
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April 2002 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00105209 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension, Pulmonary
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Intervention(s)
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Drug: Aspirin
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Drug: clopidogrel
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Primary Outcome(s)
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Urinary prostaglandin I2 (PGI-M)
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Aggregometry
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Urinary Tx-M
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Plasma P-selectin level
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Serum thromboxane B2
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Secondary Outcome(s)
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Adverse events
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Secondary ID(s)
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RR00095
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RR15534
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HL67771-01
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RR00645
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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