Back to resultsA Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
Primary Purpose
Hypertension, Pulmonary
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aspirin
clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring Platelets
Eligibility 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
Sites / Locations
- Columbia University College of Physicians and Surgeons
- Vanderbilt University Medical Center
Outcomes
Primary Outcome Measures
Plasma P-selectin level
Aggregometry
Serum thromboxane B2
Urinary Tx-M
Urinary prostaglandin I2 (PGI-M)
Secondary Outcome Measures
Adverse events
Full Information
NCT ID
NCT00105209
First Posted
March 9, 2005
Last Updated
June 23, 2005
Sponsor
Kawut, Steven, MD
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT00105209
Brief Title
A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
Official Title
A Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kawut, Steven, MD
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Columbia University
4. Oversight
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
Keywords
Platelets
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Primary Outcome Measure Information:
Title
Plasma P-selectin level
Title
Aggregometry
Title
Serum thromboxane B2
Title
Urinary Tx-M
Title
Urinary prostaglandin I2 (PGI-M)
Secondary Outcome Measure Information:
Title
Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Columbia University College of Physicians and Surgeons
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension
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