A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
This study has been completed.
Sponsor:
Kawut, Steven, MD
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
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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 Endpoint Classification: Efficacy Study 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:
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 |
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) |
| Genders Eligible for Study: | Both |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00105209
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 |
| Health Authority: | United States: Institutional Review Board |
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 September 30, 2016