A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Plasma P-selectin level
- Aggregometry
- Serum thromboxane B2
- Urinary Tx-M
- Urinary prostaglandin I2 (PGI-M)
- 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 |
| Genders Eligible for Study: | Both |
| 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
Contacts and 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 | |
More Information
No publications provided
| 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, Pulmonary Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases Aspirin Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013