Trial Outcomes & Findings for Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (NCT NCT02201771)

Results Overview

assessed by multislice computed tomography angiography (MSCTA) or coronary angiography(CAG). FitzGibbon grade A (stenosis \<50%) is defined as "patency".

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

500 participants

Primary outcome timeframe

up to 12 months

Results posted on

2019-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Aspirin aspirin 100mg tablet by mouth daily for 12 months Aspirin	Ticagrelor Plus Aspirin ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months Aspirin Ticagrelor	Ticagrelor ticagrelor 90mg tablet by mouth twice daily for 12 months Ticagrelor
Overall Study STARTED	166	168	166
Overall Study COMPLETED	153	158	156
Overall Study NOT COMPLETED	13	10	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Aspirin aspirin 100mg tablet by mouth daily for 12 months Aspirin	Ticagrelor Plus Aspirin ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months Aspirin Ticagrelor	Ticagrelor ticagrelor 90mg tablet by mouth twice daily for 12 months Ticagrelor
Overall Study Death	3	2	0
Overall Study Protocol Violation	10	8	10

Baseline Characteristics

Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin n=166 Participants aspirin 100mg tablet by mouth daily for 12 months Aspirin	Ticagrelor Plus Aspirin n=168 Participants ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months Aspirin Ticagrelor	Ticagrelor n=166 Participants ticagrelor 90mg tablet by mouth twice daily for 12 months Ticagrelor	Total n=500 Participants Total of all reporting groups
Age, Continuous	64.0 years STANDARD_DEVIATION 8.1 • n=5 Participants	63.5 years STANDARD_DEVIATION 8.2 • n=7 Participants	63.3 years STANDARD_DEVIATION 8.3 • n=5 Participants	63.6 years STANDARD_DEVIATION 8.2 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	34 Participants n=7 Participants	32 Participants n=5 Participants	91 Participants n=4 Participants
Sex: Female, Male Male	141 Participants n=5 Participants	134 Participants n=7 Participants	134 Participants n=5 Participants	409 Participants n=4 Participants
Region of Enrollment China	166 participants n=5 Participants	168 participants n=7 Participants	166 participants n=5 Participants	500 participants n=4 Participants

PRIMARY outcome

Timeframe: up to 12 months

Population: ITT analysis, Patients with missing data were considered to have occluded saphenous vein grafts.

assessed by multislice computed tomography angiography (MSCTA) or coronary angiography(CAG). FitzGibbon grade A (stenosis \<50%) is defined as "patency".

Outcome measures

Outcome measures
Measure	Aspirin n=485 saphenous vein grafts aspirin 100mg tablet by mouth daily for 12 months Aspirin	Ticagrelor Plus Aspirin n=487 saphenous vein grafts ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months Aspirin Ticagrelor	Ticagrelor n=488 saphenous vein grafts ticagrelor 90mg tablet by mouth twice daily for 12 months Ticagrelor
The Patency of Saphenous Vein Grafts	76.5 percentage of patent SV grafts Interval 70.8 to 82.1	88.7 percentage of patent SV grafts Interval 84.6 to 92.8	82.8 percentage of patent SV grafts Interval 78.0 to 87.6

SECONDARY outcome

Timeframe: up to 7 days

assessed by MSCTA or CAG. FitzGibbon grade A (stenosis \<50%) is defined as "patency".

Outcome measures

Outcome measures
Measure	Aspirin n=485 saphenous vein grafts aspirin 100mg tablet by mouth daily for 12 months Aspirin	Ticagrelor Plus Aspirin n=487 saphenous vein grafts ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months Aspirin Ticagrelor	Ticagrelor n=488 saphenous vein grafts ticagrelor 90mg tablet by mouth twice daily for 12 months Ticagrelor
The Patency of Saphenous Vein Grafts	91.1 percentage of patent SV grafts Interval 87.4 to 94.8	94.9 percentage of patent SV grafts Interval 92.2 to 97.6	94.3 percentage of patent SV grafts Interval 91.8 to 96.7

SECONDARY outcome

Timeframe: up to 7 days

Number of Participants with Post-operative Atrial Fibrillation after CABG

Outcome measures

Outcome measures
Measure	Aspirin n=166 Participants aspirin 100mg tablet by mouth daily for 12 months Aspirin	Ticagrelor Plus Aspirin n=168 Participants ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months Aspirin Ticagrelor	Ticagrelor n=166 Participants ticagrelor 90mg tablet by mouth twice daily for 12 months Ticagrelor
The Rate of Post-operative Atrial Fibrillation After CABG.	23 Participants	20 Participants	13 Participants

SECONDARY outcome

Timeframe: up to 12 months

Number of Participants Free of Angina per CCS Classification

Outcome measures

Outcome measures
Measure	Aspirin n=166 Participants aspirin 100mg tablet by mouth daily for 12 months Aspirin	Ticagrelor Plus Aspirin n=168 Participants ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months Aspirin Ticagrelor	Ticagrelor n=166 Participants ticagrelor 90mg tablet by mouth twice daily for 12 months Ticagrelor
The Rate of Freedom From Angina According to Canadian Cardiovascular Society (CCS) Classification	154 Participants	158 Participants	155 Participants

SECONDARY outcome

Timeframe: up to 12 months

MACE, composite of CV death, myocardial infarction or stroke (ischaemic or unknown etiology)

Outcome measures

Outcome measures
Measure	Aspirin n=166 Participants aspirin 100mg tablet by mouth daily for 12 months Aspirin	Ticagrelor Plus Aspirin n=168 Participants ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months Aspirin Ticagrelor	Ticagrelor n=166 Participants ticagrelor 90mg tablet by mouth twice daily for 12 months Ticagrelor
The Number of Major Adverse Cardiovascular Event (MACE)	9 events	4 events	3 events

SECONDARY outcome

Timeframe: up to 12 months

According to modified TIMI criteria, the "Major Bleeding Events" is defined as the combination of CABG-related bleeding and non-CABG-related major bleeding(Intracranial bleeding, Clinically overt signs of hemorrhage with hemoglobin drop ≥5 g/dL and Fatal bleeding).

Outcome measures

Outcome measures
Measure	Aspirin n=166 Participants aspirin 100mg tablet by mouth daily for 12 months Aspirin	Ticagrelor Plus Aspirin n=168 Participants ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months Aspirin Ticagrelor	Ticagrelor n=166 Participants ticagrelor 90mg tablet by mouth twice daily for 12 months Ticagrelor
Number of the Major Bleeding Events	0 events	3 events	2 events

OTHER_PRE_SPECIFIED outcome

Timeframe: at 12 months

Not all but the patients recruited in Ruijin Hospital

Outcome measures

Outcome data not reported

Adverse Events

Aspirin

Serious events: 9 serious events

Other events: 78 other events

Deaths: 3 deaths

Ticagrelor Plus Aspirin

Serious events: 3 serious events

Other events: 91 other events

Deaths: 2 deaths

Ticagrelor

Serious events: 3 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aspirin n=166 participants at risk aspirin 100mg tablet by mouth daily for 12 months Aspirin	Ticagrelor Plus Aspirin n=168 participants at risk ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months Aspirin Ticagrelor	Ticagrelor n=166 participants at risk ticagrelor 90mg tablet by mouth twice daily for 12 months Ticagrelor
Cardiac disorders Nonfatal myocardial infarction	1.8% 3/166 • 1 year	1.2% 2/168 • 1 year	1.2% 2/166 • 1 year
Cardiac disorders Nonfatal stroke	2.4% 4/166 • 1 year	0.00% 0/168 • 1 year	1.2% 2/166 • 1 year
Cardiac disorders Cardiovascular death	1.2% 2/166 • 1 year	0.60% 1/168 • 1 year	0.00% 0/166 • 1 year

Other adverse events

Other adverse events
Measure	Aspirin n=166 participants at risk aspirin 100mg tablet by mouth daily for 12 months Aspirin	Ticagrelor Plus Aspirin n=168 participants at risk ticagrelor 90mg tablet by mouth twice daily and aspirin 100mg tablet by mouth daily for 12 months Aspirin Ticagrelor	Ticagrelor n=166 participants at risk ticagrelor 90mg tablet by mouth twice daily for 12 months Ticagrelor
Cardiac disorders Atrial Fibrillation	15.1% 25/166 • 1 year	13.1% 22/168 • 1 year	9.0% 15/166 • 1 year
Cardiac disorders Perioperative myocardial injury	6.6% 11/166 • 1 year	14.9% 25/168 • 1 year	8.4% 14/166 • 1 year
Metabolism and nutrition disorders Hypoproteinemia	10.2% 17/166 • 1 year	13.1% 22/168 • 1 year	10.8% 18/166 • 1 year
Blood and lymphatic system disorders Anaemia	8.4% 14/166 • 1 year	6.0% 10/168 • 1 year	7.2% 12/166 • 1 year
Renal and urinary disorders Renal disfunction	3.6% 6/166 • 1 year	7.1% 12/168 • 1 year	5.4% 9/166 • 1 year
Injury, poisoning and procedural complications Incision complication	6.0% 10/166 • 1 year	5.4% 9/168 • 1 year	3.6% 6/166 • 1 year

Additional Information

Dr. Yunpeng Zhu

Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

Phone: 008613816819346

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place