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Antiplatelet Therapy After Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT02224274
Recruitment Status : Completed
First Posted : August 25, 2014
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Marko Noc, University Medical Centre Ljubljana

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cardiac Arrest
Postresuscitation Syndrome
Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)
Interventions Drug: Clopidogrel
Drug: Ticagrelor
Enrollment 57
Recruitment Details Recruitment from August 2014 to May 2016 at UMC Ljubljana, Slovenia, Europe
Pre-assignment Details Reasons for exclusion were intraprocedural eptifibatide/thrombolysis (11), decision of attending physician (8) and bradycardia (1)
Arm/Group Title Clopidogrel Ticagrelor
Hide Arm/Group Description

These patients will be treated with clopidogrel 600 mg loading and than 75 mg/24 h.

Clopidogrel

These patients will be treated with ticagrelor 180 mg loading and than 90 mg/12 h.

Ticagrelor

Period Title: Overall Study
Started 17 20
Completed 16 20
Not Completed 1 0
Reason Not Completed
Death             1             0
Arm/Group Title Clopidogrel Ticagrelor Total
Hide Arm/Group Description These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h. These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h. Total of all reporting groups
Overall Number of Baseline Participants 16 20 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 20 participants 36 participants
64  (9) 61  (12) 62  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 20 participants 36 participants
Female
3
  18.8%
3
  15.0%
6
  16.7%
Male
13
  81.3%
17
  85.0%
30
  83.3%
ST-Elevation Myocardial Infarction in postresuscitation ECG  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 20 participants 36 participants
12
  75.0%
16
  80.0%
28
  77.8%
1.Primary Outcome
Title VerifyNow P2Y12Test - Platelet Reactivity
Hide Description 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.
Time Frame 12 h after P2Y12 inhibitor loading
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Ticagrelor
Hide Arm/Group Description:
These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.
These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
Overall Number of Participants Analyzed 16 20
Mean (Standard Deviation)
Unit of Measure: PRU
238  (67) 101  (75)
2.Secondary Outcome
Title VerifyNow P2Y12Test - % Inhibition
Hide Description % 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.
Time Frame 12 hours after P2Y12 inhibitor loading
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Ticagrelor
Hide Arm/Group Description:
These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.
These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
Overall Number of Participants Analyzed 16 20
Mean (Standard Deviation)
Unit of Measure: % inhibition
4  (11) 55  (32)
3.Secondary Outcome
Title Multiplate ADP Test
Hide Description

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.

Time Frame 12 hours after P2Y12 inhibitor loading
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clopidogrel Ticagrelor
Hide Arm/Group Description:
These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h.
These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
Overall Number of Participants Analyzed 16 20
Mean (Standard Deviation)
Unit of Measure: U
28  (17) 15  (10)
Time Frame From the date of randomization until hospital discharge or death during hospitalization.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clopidogrel Ticagrelor
Hide Arm/Group Description These patients were treated with clopidogrel 600 mg loading and than 75 mg/24 h. These patients were treated with ticagrelor 180 mg loading and than 90 mg/12 h.
All-Cause Mortality
Clopidogrel Ticagrelor
Affected / at Risk (%) Affected / at Risk (%)
Total   7/16 (43.75%)      9/20 (45.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Clopidogrel Ticagrelor
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/16 (43.75%)      9/20 (45.00%)    
Cardiac disorders     
Death *  7/16 (43.75%)  7 9/20 (45.00%)  9
Nervous system disorders     
Cerebrovascular insult *  1/16 (6.25%)  1 1/20 (5.00%)  1
Surgical and medical procedures     
Bleeding Academic Research Consortium (BARC) 3a and 5 *  2/16 (12.50%)  2 3/20 (15.00%)  3
Stent thrombosis *  1/16 (6.25%)  1 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clopidogrel Ticagrelor
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/16 (62.50%)      10/20 (50.00%)    
Blood and lymphatic system disorders     
Minor bleeding *  2/16 (12.50%)  2 1/20 (5.00%)  1
Cardiac disorders     
Bradycardia/asystoly *  0/16 (0.00%)  0 1/20 (5.00%)  1
Ventricular tachycardia *  0/16 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
Aspiration Pneumonia *  8/16 (50.00%)  8 7/20 (35.00%)  7
Vascular disorders     
Arterial embolism *  1/16 (6.25%)  1 0/20 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Did not address effectiveness of prasugrel. Not powered to address stent thrombosis or bleeding.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marko Noc
Organization: UMC Ljubljana
Phone: +386 1 522 22 96
Publications:
Responsible Party: Marko Noc, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02224274     History of Changes
Other Study ID Numbers: Hypothermia: Clopi vs Tica
First Submitted: August 19, 2014
First Posted: August 25, 2014
Results First Submitted: January 23, 2017
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019