Trial Outcomes & Findings for Platelet Reactivity (High On-Treatment Platelet Reactivity) as Guidance for APT (Antiplatelet Therapy) Adjustment After PCI (Percutaneous Coronary Intervention) (NCT NCT02101411)

NCT ID: NCT02101411

Last Updated: 2019-11-22

Results Overview

MACE(major adverse cardiac event) include: death, myocardial infarction, revascularization.

• Recruitment status: COMPLETED
• Target enrollment: 334 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2019-11-22

Participant Flow

Participant milestones

Measure	Aspirin+Clopidogrel aspirin 100mg qd+clopidogrel 75mg qd	Aspirin+Ticagrelor aspirin100mg qd+ticagrelor 90mg bid	Aspirin+Clopidogrel+Cilostazol aspirin 100mg qd+clopidogrel 75mg qd+cilostazol 100mg bid
Overall Study STARTED	111	109	114
Overall Study COMPLETED	107	102	104
Overall Study NOT COMPLETED	4	7	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Platelet Reactivity (High On-Treatment Platelet Reactivity) as Guidance for APT (Antiplatelet Therapy) Adjustment After PCI (Percutaneous Coronary Intervention)

Baseline characteristics by cohort

Measure	Aspirin+Clopidogrel n=107 Participants aspirin 100mg qd+clopidogrel 75mg q...	Aspirin+Ticagrelor n=102 Participants aspirin100mg qd+ticagrelor 90mg bid	Aspirin+Clopidogrel+Cilostazol n=104 Participants aspirin 100mg qd+clopidogrel 75mg q...	Total n=313 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=93 Participants	83 Participants n=4 Participants	80 Participants n=27 Participants	249 Participants n=483 Participants
Age, Categorical >=65 years	21 Participants n=93 Participants	19 Participants n=4 Participants	24 Participants n=27 Participants	64 Participants n=483 Participants
Age, Continuous	65.4 years STANDARD_DEVIATION 13 • n=93 Participants	66.1 years STANDARD_DEVIATION 13.9 • n=4 Participants	65.2 years STANDARD_DEVIATION 13.4 • n=27 Participants	65.8 years STANDARD_DEVIATION 13.2 • n=483 Participants
Sex: Female, Male Female	33 Participants n=93 Participants	29 Participants n=4 Participants	24 Participants n=27 Participants	86 Participants n=483 Participants
Sex: Female, Male Male	74 Participants n=93 Participants	73 Participants n=4 Participants	80 Participants n=27 Participants	227 Participants n=483 Participants
Region of Enrollment Taiwan	107 participants n=93 Participants	102 participants n=4 Participants	104 participants n=27 Participants	313 participants n=483 Participants

PRIMARY outcome

Timeframe: 24 months

MACE(major adverse cardiac event) include: death, myocardial infarction, revascularization.

Outcome measures

Measure	Aspirin+Clopidogrel n=107 Participants aspirin 100mg qd+clopidogrel 75mg qd	Aspirin+Ticagrelor n=102 Participants aspirin100mg qd+ticagrelor 90mg bid	Aspirin+Clopidogrel+Cilostazol n=104 Participants aspirin 100mg qd+clopidogrel 75mg qd+cilostazol 100mg bid
Numbers of Participants With MACE(Major Adverse Cardiac Event) of Study Subjects	1 numbers of participants with MACE	1 numbers of participants with MACE	2 numbers of participants with MACE

Adverse Events

Aspirin+Clopidogrel

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Aspirin+Ticagrelor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Aspirin+Clopidogrel+Cilostazol

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Aspirin+Clopidogrel n=107 participants at risk aspirin 100mg qd+clopidogrel 75mg qd	Aspirin+Ticagrelor n=102 participants at risk aspirin100mg qd+ticagrelor 90mg bid	Aspirin+Clopidogrel+Cilostazol n=104 participants at risk aspirin 100mg qd+clopidogrel 75mg qd+cilostazol 100mg bid
Blood and lymphatic system disorders 1	0.93% 1/107 • Number of events 1 • 24m	0.00% 0/102 • 24m	1.9% 2/104 • Number of events 2 • 24m

Other adverse events

Adverse event data not reported

Additional Information

chen yueh-chung

taipei city hospital

Phone: 88627093600

Email: chenyuehchung.tw@yahoo.com.tw

Results disclosure agreements

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