Trial Outcomes & Findings for Aspirin Dosing in Diabetic Patients (NCT NCT01201785)

Results Overview

Collagen induced aggregation using light transmittance aggregometry

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

after 1 -week of treatment

Results posted on

2012-03-06

Participant Flow

From January 2009 to April 2010 patients were recruited at the outpatient clinic of the Division of Cardiology at Shands Jacksonville Hospital.

A total of 82 patients were screened; 48 were eligible and 36 agreed to provide their written consent. Of these, 16 did not complete all 5 treatment regimens. Therefore, a total of 20 completed all the study phases and used for analysis.

Participant milestones

Participant milestones
Measure	Aspirin Dose Range Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
Overall Study STARTED	36
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Aspirin Dose Range Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
Overall Study Lost to Follow-up	16

Baseline Characteristics

Aspirin Dosing in Diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin Dose Range n=36 Participants Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age Continuous	59 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: after 1 -week of treatment

Population: A 20% SD for the difference between collagen-induced platelet aggregation in patients on aspirin 81 mg od versus 81 mg bid was assumed, and based on a power of 80% and a significance level of 0.05. Based on these values, we determined that a sample population of 20 patients would be needed.

Collagen induced aggregation using light transmittance aggregometry

Outcome measures

Outcome measures
Measure	Aspirin Dose Range n=20 Participants Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
Collagen Induced Aggregation	32 percentage of platelet aggregation Standard Deviation 14

Adverse Events

Aspirin Dose Range

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

Dominick J. Angiolillo, MD, PhD

University of Florida-Jacksonville

Phone: 904-244-3933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place