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Trial Outcomes & Findings for Aspirin Responsiveness in Women at Risk for Cardiac Events (NCT NCT00818337)

NCT ID: NCT00818337

Last Updated: 2012-12-04

Results Overview

Aspirin responsive unit (ARU) \> 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

Baseline

Results posted on

2012-12-04

Participant Flow

Participant milestones

Participant milestones
Measure
Aspirin 81mg
Aspirin 81mg at baseline
Overall Study
STARTED
36
Overall Study
COMPLETED
36
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspirin Responsiveness in Women at Risk for Cardiac Events

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Aspirin 81mg
n=36 Participants
Aspirin 81mg at baseline
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
35 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Age Continuous
Non-resistant to 81 mg
52.6 years
STANDARD_DEVIATION 8.3 • n=5 Participants
Age Continuous
Resistant to 81 mg
56.7 years
STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male
Female
36 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Region of Enrollment
United States
36 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Aspirin responsive unit (ARU) \> 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.

Outcome measures

Outcome measures
Measure
Aspirin 81 mg
n=36 Participants
Aspirin 81 mg at baseline
Number of Women Aspirin Resistant
3 participants

SECONDARY outcome

Timeframe: 2 weeks

Aspirin resistance was defined as ARU \> 550

Outcome measures

Outcome measures
Measure
Aspirin 81 mg
n=3 Participants
Aspirin 81 mg at baseline
Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg
3 participants

Adverse Events

Aspirin 81mg

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

Kathleen Packard, PharmD

Creighton University

Phone: 402-280-2668

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place