Trial Outcomes & Findings for Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis (NCT NCT02053909)

Results Overview

The primary objective of this clinical trial will be to evaluate whether, as compared to usual aspirin treatment, ticagrelor early after CABG prevents saphenous vein graft occlusion 1 year after surgery, as assessed by computed tomography (CT) coronary angiography.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

250 participants

Primary outcome timeframe

1 year after surgery

Results posted on

2022-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	Aspirin One aspirin 81 mg capsule 2 times per day Aspirin	Ticagrelor One ticagrelor 90 mg capsule 2 times per day Ticagrelor
Overall Study STARTED	123	127
Overall Study COMPLETED	123	127
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin n=123 Participants aspirin group	Ticagrelor n=127 Participants ticagrelor group	Total n=250 Participants Total of all reporting groups
Age, Continuous	68.0 years STANDARD_DEVIATION 9.0 • n=123 Participants	67.5 years STANDARD_DEVIATION 9.3 • n=127 Participants	68.0 years STANDARD_DEVIATION 9.0 • n=250 Participants
Sex: Female, Male Female	16 Participants n=123 Participants	23 Participants n=127 Participants	39 Participants n=250 Participants
Sex: Female, Male Male	107 Participants n=123 Participants	104 Participants n=127 Participants	211 Participants n=250 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 1 year after surgery

Population: Vein graft occlusion reported as percentage

The primary objective of this clinical trial will be to evaluate whether, as compared to usual aspirin treatment, ticagrelor early after CABG prevents saphenous vein graft occlusion 1 year after surgery, as assessed by computed tomography (CT) coronary angiography.

Outcome measures

Outcome measures
Measure	Aspirin n=172 Vein grafts One aspirin 81 mg capsule 2 times per day Aspirin	Ticagrelor n=166 Vein grafts One ticagrelor 90 mg capsule 2 times per day Ticagrelor
Saphenous Vein Graft Occlusion	17.4 percentage of veins occluded	13.2 percentage of veins occluded

SECONDARY outcome

Timeframe: 1 year after surgery

Population: Vein graft stenosis reported as percentage

The secondary objective of this clinical trial will be to evaluate whether, as compared to usual aspirin treatment, ticagrelor early after CABG prevents saphenous vein graft stenosis, defined as \>50% narrowing of the graft, 1 year after surgery, as assessed by computed tomography (CT) coronary angiography.

Outcome measures

Outcome measures
Measure	Aspirin n=172 Vein grafts One aspirin 81 mg capsule 2 times per day Aspirin	Ticagrelor n=166 Vein grafts One ticagrelor 90 mg capsule 2 times per day Ticagrelor
Saphenous Vein Graft Stenosis	4.1 percentage of veins stenosed	4.2 percentage of veins stenosed

Adverse Events

Aspirin

Serious events: 5 serious events

Other events: 0 other events

Deaths: 2 deaths

Ticagrelor

Serious events: 9 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Aspirin n=123 participants at risk One aspirin 81 mg capsule 2 times per day Aspirin	Ticagrelor n=127 participants at risk One ticagrelor 90 mg capsule 2 times per day Ticagrelor
Blood and lymphatic system disorders Bleeding	4.1% 5/123 • 1 year	7.1% 9/127 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alexander Kulik

Boca Raton Regional Hospital

Phone: 561-955-6300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place