A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
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ClinicalTrials.gov Identifier: NCT00105209 |
Recruitment Status
:
Completed
First Posted
: March 10, 2005
Last Update Posted
: June 24, 2005
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension, Pulmonary | Drug: Aspirin Drug: clopidogrel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
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 |
Study Start Date : | April 2002 |
Study Completion Date : | December 2003 |

- Plasma P-selectin level
- Aggregometry
- Serum thromboxane B2
- Urinary Tx-M
- Urinary prostaglandin I2 (PGI-M)
- Adverse events

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105209
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 |
ClinicalTrials.gov Identifier: | NCT00105209 History of Changes |
Other Study ID Numbers: |
HL67771-01 RR00645 RR00095 RR15534 |
First Posted: | March 10, 2005 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | March 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 |