NCT00105209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2005

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 2005

First QC Date

March 9, 2005

Last Update Submit

June 23, 2005

Conditions

Hypertension, Pulmonary

Keywords

Platelets

Outcome Measures

Primary Outcomes (5)

  • Plasma P-selectin level

  • Aggregometry

  • Serum thromboxane B2

  • Urinary Tx-M

  • Urinary prostaglandin I2 (PGI-M)

Secondary Outcomes (1)

  • Adverse events

Interventions

AspirinDRUG
clopidogrelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

AspirinClopidogrel

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV

Study Record Dates

First Submitted

March 9, 2005

First Posted

March 10, 2005

Study Start

April 1, 2002

Study Completion

December 1, 2003

Last Updated

June 24, 2005

Record last verified: 2005-03

Locations

US(2)