Trial Outcomes & Findings for Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery (NCT NCT02291419)

Results Overview

Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.

Results posted on

2017-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Ticagrelor ticagrelor 90mg bid ticagrelor: ticagrelor 90 mg bid	Aspirin Patients in the aspirin arm will receive aspirin 81 mg daily orally aspirin: aspirin 81 mg daily
Overall Study STARTED	1	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Ticagrelor ticagrelor 90mg bid ticagrelor: ticagrelor 90 mg bid	Aspirin Patients in the aspirin arm will receive aspirin 81 mg daily orally aspirin: aspirin 81 mg daily
Overall Study Early study termination	1	5

Baseline Characteristics

Study of Ticagrelor Versus Aspirin Treatment in Patients With Myocardial Injury Post Major Non-cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ticagrelor n=1 Participants ticagrelor 90mg bid ticagrelor: ticagrelor 90 mg bid	Aspirin n=5 Participants Patients in the aspirin arm will receive aspirin 81 mg daily orally aspirin: aspirin 81 mg daily	Total n=6 Participants Total of all reporting groups
Age, Customized > or = to 40 years	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.

Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported.

Outcome measures

Outcome measures
Measure	Ticagrelor n=1 Participants ticagrelor 90mg bid ticagrelor: ticagrelor 90 mg bid	Aspirin n=5 Participants Patients in the aspirin arm will receive aspirin 81 mg daily orally aspirin: aspirin 81 mg daily
Major Adverse Cardiovascular Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.

Time to first occurence of Cardiovascular death. The number of patients with events was reported.

Outcome measures

Outcome measures
Measure	Ticagrelor n=1 Participants ticagrelor 90mg bid ticagrelor: ticagrelor 90 mg bid	Aspirin n=5 Participants Patients in the aspirin arm will receive aspirin 81 mg daily orally aspirin: aspirin 81 mg daily
Cardiovascular Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.

Time to first occurence of Non-fatal myocardial infarction or coronary revascularization. The number of participants with events was reported.

Outcome measures

Outcome measures
Measure	Ticagrelor n=1 Participants ticagrelor 90mg bid ticagrelor: ticagrelor 90 mg bid	Aspirin n=5 Participants Patients in the aspirin arm will receive aspirin 81 mg daily orally aspirin: aspirin 81 mg daily
Non-fatal Myocardial Infarction or Coronary Revascularization	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.

Time to first occurence of All-cause death. The number of participants with events was reported.

Outcome measures

Outcome measures
Measure	Ticagrelor n=1 Participants ticagrelor 90mg bid ticagrelor: ticagrelor 90 mg bid	Aspirin n=5 Participants Patients in the aspirin arm will receive aspirin 81 mg daily orally aspirin: aspirin 81 mg daily
All-cause Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.

Time to first occurence of Non-fatal stroke. The number of participants with events was reported.

Outcome measures

Outcome measures
Measure	Ticagrelor n=1 Participants ticagrelor 90mg bid ticagrelor: ticagrelor 90 mg bid	Aspirin n=5 Participants Patients in the aspirin arm will receive aspirin 81 mg daily orally aspirin: aspirin 81 mg daily
Non-fatal Stroke	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.

Outcome measures

Outcome measures
Measure	Ticagrelor n=1 Participants ticagrelor 90mg bid ticagrelor: ticagrelor 90 mg bid	Aspirin n=5 Participants Patients in the aspirin arm will receive aspirin 81 mg daily orally aspirin: aspirin 81 mg daily
The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions	0 Participants	0 Participants

Adverse Events

Ticagrelor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Dr. Venu Menon

Cleveland Clinic

Phone: 216-445-5390

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place