DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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 level


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).


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017