Antiplatelet Therapy After Cardiac Arrest

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction); Cardiac Arrest; Postresuscitation Syndrome

Treatments: Drug: Ticagrelor; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT02224274

Hypothermia: Clopi vs Tica

Details and patient eligibility

About

There is growing evidence that standard dual antiplatelet therapy with acetylsalicylic acid (ASA) and clopidogrel is not as effective in the setting of therapeutic hypothermia after cardiac arrest as in normothermic patients. The reasons for this are probably slower gastrointestinal motility, absorption and liver metabolism required for clopidogrel to take action. Since ticagrelor has faster intestinal absorption and no need for liver metabolism we expect its effect to be good even in patients with therapeutic hypothermia after cardiac arrest. Patients treated with therapeutic hypothermia after cardiac arrest and percutaneous coronary intervention will be randomised into two groups. One will be treated with ASA and clopidogrel and the other with ASA and ticagrelor. Blood samples will be collected before and 2, 4, 12, 22 and 48 hours after P2Y12 inhibitor administration. Platelet function will be measured by VerifyNow P2Y12 assay and by Multiplate ADPTest. Differences between the groups will be analysed.

Hypothesis: Antiplatelet therapy with ticagrelor is more effective than therapy with clopidogrel in the comatose survivors of cardiac arrest treated with therapeutic hypothermia and percutaneous coronary intervention (PCI).

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male over 18 years old
• Unconscious survivors of cardiac arrest treated with therapeutic hypothermia
• Acute coronary syndrome (NSTEMI or STEMI) as a reason of cardiac arrest
• PCI with stent implantation
• Provision of informed consent prior to any study specific procedures is impossible because subjects are unconscious at the moment of inclusion

Exclusion criteria

• Use of any P2Y12 inhibitors in last 10 days
• Use of prasugrel before and 48 hours after loading dose of P2Y12 inhibitor
• Use of eptifibatide before and 48 hours after loading dose of P2Y12 inhibitor
• Thrombocytopenia (<50*109/L)
• Allergic reaction to acetylsalicylic acid, clopidogrel or ticagrelor
• Ticagrelor contraindications: previous intracranial bleeding, active pathological bleeding, moderate to severe hepatic impairment, heart rate < 40/min at presentation
• Suspected or confirmed pregnancy
• Use of bivalirudin before and 48 hours after loading dose of P2Y12 inhibitor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Clopidogrel

Active Comparator group

Description:

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

Treatment:

Drug: Clopidogrel

Ticagrelor

Experimental group

Description:

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

Treatment:

Drug: Ticagrelor