Trial Outcomes & Findings for Aspirin in Patients With Myocardial Infarction and Thrombocytopenia (NCT NCT00501345)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

5 participants

Primary outcome timeframe

7 Days

Results posted on

2012-08-01

Participant Flow

Recruitment Period: 02/28/02 through 04/22/04. All participants recruited at UT MD Anderson Cancer Center.

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.

Participant milestones

Participant milestones
Measure	Aspirin 325 mg by mouth Day 1, 160 mg daily thereafter
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspirin in Patients With Myocardial Infarction and Thrombocytopenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin n=5 Participants 325 mg by mouth Day 1, 160 mg daily thereafter
Age Continuous	78 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 Days

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Aspirin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jean-Bernard Durand, MD / Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place