Overview

Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction

Status:
Recruiting
Trial end date:
2024-05-01
Target enrollment:
0
Participant gender:
All
Summary
Multicenter randomized double blind trial comparing intravenous cangrelor and oral ticagrelor in patients with acute myocardial infarction complicated by initial cardiogenic shock and treated with primary angioplasty.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Faculty Hospital Kralovske Vinohrady
Collaborator:
Charles University, Czech Republic
Treatments:
Cangrelor
Ticagrelor
Criteria
Inclusion Criteria:

1. Age over 18 years

2. Acute myocardial infarction according to the definition of ESC/ACC/AHA, indicated for
emergency percutaneous coronary intervention (primary PCI strategy)

3. Cardiogenic shock present upon admission due to the AMI (≥ 2 of the criteria below are
satisfied)24

1. sBP < 90 mmHg with the absence of hypovolemia

2. Need of vasopressor and/or inotropic therapy

3. Presence of the signs of the organ hypoperfusion - cyanosis, cold acra, disorder
of consciousness, congestive heart failure

4. Informed consent form signed.

Exclusion Criteria:

1. Contraindications of antiplatelet therapy with ticagrelor/cangrelor25

- Recent (< 6 months) major bleeding

- Recent (< 1 month) major surgery/injury

- History of intracranial bleeding

- History of stroke/TIA

- Known intolerance to ticagrelor/cangrelor

- Severe impairment of hepatic function

- Concomitant administration of strong CYP3A4 inhibitors (for example,
ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)

2. Administration of a loading dose of an oral P2Y12 inhibitor prior to admission
(clopidogrel ≥ 300 mg, ticagrelor 180 mg, prasugrel 60 mg)

3. Need of concomitant chronic anticoagulation therapy due to indications such as atrial
fibrillation, artificial valve, thromboembolic disease, etc.