Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction

Summary

Multicenter, international, randomized, placebo-controlled, double-blind trial comparing intravenous cangrelor and crushed oral ticagrelor in patients with acute myocardial infarction complicated by initial cardiogenic shock (CS-AMI) and treated with primary angioplasty (PCI).

The Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction (DAPT-SHOCK-AMI) trial tests the hypothesis that intravenous cangrelor is (a) more effective in terms of its rate of onset and the proportion of patients achieving effective periprocedural inhibition of ADP-induced platelet aggregation and (b) at least as effective as the recommended treatment of oral (crushed) ticagrelor in reducing major cardiovascular events in patients with initial CS-AMI indicated for primary PCI strategy.

Conditions

• Acute Myocardial Infarction
• Cardiogenic Shock

Interventions

DRUG

Cangrelor

Cangrelor: IV bolus 30 µg/kg (application \< 1 minute) followed immediately by continuous infusion at 4 µg/kg. Tables to calculate bolus dose in ml and infusion (in ml per hour) rate for each body weight group will be prepared in advance and will be included in the study medication kit to accelerate treatment start. * Cangrelor treatment will be discontinued after circulatory stabilization (but no earlier than 2 hours after infusion initiation) i.e. after systolic Blood Pressure (sBP) is maintained at the level \> 100 mmHg for one hour after the end of IABK and/or vasoactive treatment is discontinued, but no later than 4 hours after PCI, * 30 minutes before the end of Cangrelor infusion, administration of Ticagrelor 180 mg (crushed tablets) and then dose 90 mg every 12 hours.

DRUG

Ticagrelor

Ticagrelor: 180 mg loading dose - crushed tablets, 2 x 90 mg maintenance dose

Sponsors & Collaborators

• Charles University, Czech Republic

  collaborator OTHER

• Masaryk University

  collaborator OTHER

• Ministry of Health, Czech Republic

  collaborator OTHER_GOV

• National Institute for Metabolic and Cardiovascular Disease Research

  collaborator UNKNOWN

• Institute of Hematology and Blood Transfusion, Czech Republic

  collaborator OTHER

• BioVendor LM

  collaborator UNKNOWN

• Faculty Hospital Kralovske Vinohrady

  lead OTHER_GOV

Principal Investigators

• Zuzana Motovska, MD, PhD. · University Hospital Kralovske Vinohrady, Charles University, Prague, Czech Republic

• Deepak L Bhatt, MD, MPH, MBA. · Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-01

Primary Completion

2024-02-19

Completion

2025-04-01

Countries

• Czechia
• France
• Germany
• Poland
• Slovakia

Study Locations