Trial Outcomes & Findings for Antiplatelet Therapy After Cardiac Arrest (NCT NCT02224274)

NCT ID: NCT02224274

Last Updated: 2019-02-27

Results Overview

Platelet reactivity reflects P2Y12 inhibitor effect. Higher values mean normal platelet reactivity due to low P2Y12 inhibition response, while lower values mean decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as \>208 PRU.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 57 participants
• Primary outcome timeframe: 12 h after P2Y12 inhibitor loading
• Results posted on: 2019-02-27

Participant Flow

Recruitment from August 2014 to May 2016 at UMC Ljubljana, Slovenia, Europe

Reasons for exclusion were intraprocedural eptifibatide/thrombolysis (11), decision of attending physician (8) and bradycardia (1)

Participant milestones

Measure	Clopidogrel These patients will be treated with clopidogrel 600 mg loading and than 75 mg/24 h. Clopidogrel	Ticagrelor These patients will be treated with ticagrelor 180 mg loading and than 90 mg/12 h. Ticagrelor
Overall Study STARTED	17	20
Overall Study COMPLETED	16	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Clopidogrel These patients will be treated with clopidogrel 600 mg loading and than 75 mg/24 h. Clopidogrel	Ticagrelor These patients will be treated with ticagrelor 180 mg loading and than 90 mg/12 h. Ticagrelor
Overall Study Death	1	0

Baseline Characteristics

Antiplatelet Therapy After Cardiac Arrest

Baseline characteristics by cohort

Measure	Clopidogrel n=16 Participants These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.	Ticagrelor n=20 Participants These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.	Total n=36 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 9 • n=5 Participants	61 years STANDARD_DEVIATION 12 • n=7 Participants	62 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
ST-Elevation Myocardial Infarction in postresuscitation ECG	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 h after P2Y12 inhibitor loading

Platelet reactivity reflects P2Y12 inhibitor effect. Higher values mean normal platelet reactivity due to low P2Y12 inhibition response, while lower values mean decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as >208 PRU.

Outcome measures

Measure	Clopidogrel n=16 Participants These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.	Ticagrelor n=20 Participants These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
VerifyNow P2Y12Test - Platelet Reactivity	238 PRU Standard Deviation 67	101 PRU Standard Deviation 75

SECONDARY outcome

Timeframe: 12 hours after P2Y12 inhibitor loading

% inhibition reflects P2Y12 inhibitor effect regarding basal platelet reactivity (defined as: (1- (platelet reactivity/basal platelet reactivity)) x 100). Higher values mean better P2Y12 inhibition response. High on-treatment platelet reactivity was defined as <11% inhibition.

Outcome measures

Measure	Clopidogrel n=16 Participants These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.	Ticagrelor n=20 Participants These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
VerifyNow P2Y12Test - % Inhibition	4 % inhibition Standard Deviation 11	55 % inhibition Standard Deviation 32

SECONDARY outcome

Timeframe: 12 hours after P2Y12 inhibitor loading

Platelet activation by adenosine diphosphate (ADP) expressed in arbitrary aggregation units (U). P2Y12 inhibitors block ADP receptors and decrease platelet activation by ADP. Higher values mean less effect of P2Y12 inhibitors, lower values mean more effect of P2Y12 inhibitors on platelets.

High on-treatment platelet reactivity was defined as >46 U.

Outcome measures

Measure	Clopidogrel n=16 Participants These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.	Ticagrelor n=20 Participants These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
Multiplate ADP Test	28 U Standard Deviation 17	15 U Standard Deviation 10

Adverse Events

Clopidogrel

Serious events: 7 serious events

Other events: 10 other events

Deaths: 7 deaths

Ticagrelor

Serious events: 9 serious events

Other events: 10 other events

Deaths: 9 deaths

Serious adverse events

Measure	Clopidogrel n=16 participants at risk These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.	Ticagrelor n=20 participants at risk These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
Cardiac disorders Death	43.8% 7/16 • Number of events 7 • From the date of randomization until hospital discharge or death during hospitalization.	45.0% 9/20 • Number of events 9 • From the date of randomization until hospital discharge or death during hospitalization.
Surgical and medical procedures Bleeding Academic Research Consortium (BARC) 3a and 5	12.5% 2/16 • Number of events 2 • From the date of randomization until hospital discharge or death during hospitalization.	15.0% 3/20 • Number of events 3 • From the date of randomization until hospital discharge or death during hospitalization.
Surgical and medical procedures Stent thrombosis	6.2% 1/16 • Number of events 1 • From the date of randomization until hospital discharge or death during hospitalization.	5.0% 1/20 • Number of events 1 • From the date of randomization until hospital discharge or death during hospitalization.
Nervous system disorders Cerebrovascular insult	6.2% 1/16 • Number of events 1 • From the date of randomization until hospital discharge or death during hospitalization.	5.0% 1/20 • Number of events 1 • From the date of randomization until hospital discharge or death during hospitalization.

Other adverse events

Measure	Clopidogrel n=16 participants at risk These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.	Ticagrelor n=20 participants at risk These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
Respiratory, thoracic and mediastinal disorders Aspiration Pneumonia	50.0% 8/16 • Number of events 8 • From the date of randomization until hospital discharge or death during hospitalization.	35.0% 7/20 • Number of events 7 • From the date of randomization until hospital discharge or death during hospitalization.
Blood and lymphatic system disorders Minor bleeding	12.5% 2/16 • Number of events 2 • From the date of randomization until hospital discharge or death during hospitalization.	5.0% 1/20 • Number of events 1 • From the date of randomization until hospital discharge or death during hospitalization.
Cardiac disorders Bradycardia/asystoly	0.00% 0/16 • From the date of randomization until hospital discharge or death during hospitalization.	5.0% 1/20 • Number of events 1 • From the date of randomization until hospital discharge or death during hospitalization.
Vascular disorders Arterial embolism	6.2% 1/16 • Number of events 1 • From the date of randomization until hospital discharge or death during hospitalization.	0.00% 0/20 • From the date of randomization until hospital discharge or death during hospitalization.
Cardiac disorders Ventricular tachycardia	0.00% 0/16 • From the date of randomization until hospital discharge or death during hospitalization.	5.0% 1/20 • Number of events 1 • From the date of randomization until hospital discharge or death during hospitalization.

Additional Information

Marko Noc

UMC Ljubljana

Phone: +386 1 522 22 96

Email: marko.noc@mf.uni-lj.si

Results disclosure agreements

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