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Aspirin in Patients With Myocardial Infarction and Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT00501345
Recruitment Status : Terminated (Low accrual, study terminated.)
First Posted : July 16, 2007
Results First Posted : October 13, 2010
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Thrombocytopenia
Myocardial Infarction
Intervention Drug: Aspirin
Enrollment 5
Recruitment Details Recruitment Period: 02/28/02 through 04/22/04. All participants recruited at UT MD Anderson Cancer Center.
Pre-assignment Details Study terminated as a result of difficulty in accrual of candidate patients for enrollment. Six patients were enrolled but one patient did not meet eligibility criteria.
Arm/Group Title Aspirin
Hide Arm/Group Description 325 mg by mouth Day 1, 160 mg daily thereafter
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Aspirin
Hide Arm/Group Description 325 mg by mouth Day 1, 160 mg daily thereafter
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
78
(39 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Participants With 7 Days Observation Without Severe Bleeding
Hide Description Blood samples collected at baseline before or after aspirin is given and at 24 hours, 72 hours and 7 days after treatment has been initiated for those that remain in the study after the first 24 hours.
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The baseline Thromboelastogram showed normal platelet function in all patients and no evidence of heparin induced thrombocytopenia (HIT). No further analysis was done as study was terminated due to lack of accrual.
Arm/Group Title Aspirin
Hide Arm/Group Description:
325 mg by mouth Day 1, 160 mg daily thereafter
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 Years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin
Hide Arm/Group Description 325 mg by mouth Day 1, 160 mg daily thereafter
All-Cause Mortality
Aspirin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aspirin
Affected / at Risk (%)
Total   0/0 
A change in hospital practice where patients with thrombocytopenia now routinely receive aspirin for acute coronary syndromes makes it difficult to obtain a baseline thromboelastogram.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jean-Bernard Durand, MD / Professor
Organization: UT MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00501345     History of Changes
Other Study ID Numbers: ID01-674
First Submitted: July 13, 2007
First Posted: July 16, 2007
Results First Submitted: September 24, 2009
Results First Posted: October 13, 2010
Last Update Posted: August 1, 2012