NCT03551964CompletedPhase 4
Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction
Cangrelor Versus Ticagrelor In Patients With Acute Myocardial Infarction Complicated With Initial Cardiogenic Shock
Source: ClinicalTrials.gov · Last updated 2 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 605 (actual)
- First submitted
- 29 May 2018
- Start date
- 1 Aug 2018
- Primary completion date
- 19 Feb 2024
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Diseases
- Coronary artery disease
- NCT number
- NCT03551964
- EudraCT number
- 2018-002161-19
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 605
- From 1 Aug 2018 to the primary completion date, 19 Feb 2024
- 29 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications of antiplatelet therapy with ticagrelor/cangrelor
- 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)
- Administration of a loading dose of an oral P2Y12 inhibitor prior to admission (clopidogrel ≥ 300 mg, ticagrelor 180 mg, prasugrel 60 mg)
- Need of concomitant chronic anticoagulation therapy due to indications such as atrial fibrillation, artificial valve, thromboembolic disease, etc.
Who the study is looking for
- Age over 18 years
- Acute myocardial infarction according to the definition of ESC/ACC/AHA, indicated for emergency percutaneous coronary intervention (primary PCI strategy)
- Cardiogenic shock present upon admission due to the AMI (≥ 2 of the criteria below are satisfied)
- sBP \< 90 mmHg with the absence of hypovolemia
- Need of vasopressor and/or inotropic therapy
- Presence of the signs of the organ hypoperfusion - cyanosis, cold acra, disorder of consciousness, congestive heart failure
- Informed consent form signed
- Women of childbearing potential should be protected from pregnancy throughout the study (relevant for long-term use of ticagrelor). Suitable methods of contraception in this case include hormonal contraceptives, barrier methods, or complete withdrawal - as long as it is consistent with the patient's lifestyle.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Anne's University Hospital Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Department of Cardiology, University Hospital Brno-Bohunice Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Cardiology Department, Regional Hospital Coordinator of this site? Confirm its status | České Budějovice | Czechia | Unknown status |
| University Hospital Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| Cardiology department, Regional hospital Coordinator of this site? Confirm its status | Jihlava | Czechia | Unknown status |
| Cardiocenter, Regional Hospital Coordinator of this site? Confirm its status | Karlovy Vary | Czechia | Unknown status |
| Krajská nemocnice Liberec Coordinator of this site? Confirm its status | Liberec | Czechia | Unknown status |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| University Hospital Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Department of Cardiology, Regional Hospital, Coordinator of this site? Confirm its status | Pardubice | Czechia | Unknown status |
| University Hospital Pilsen Coordinator of this site? Confirm its status | Pilsen | Czechia | Unknown status |
| University Hospital Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Na Homolce Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Institute of Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| General University Hospital in Prague Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Cardiocenter, Hospital Podlesi Coordinator of this site? Confirm its status | Třinec | Czechia | Unknown status |
| Masaryk Hospital Coordinator of this site? Confirm its status | Ústí nad Labem | Czechia | Unknown status |
| Regional Hospital T. Bati Coordinator of this site? Confirm its status | Zlín | Czechia | Unknown status |
| Heart Center Freiburg University Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Unknown status |
| University Medical Centre Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| University Hospital Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Département de Cardiologie, Hôpital Bichat Assistance Publique Hôpitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Pitié-Salpêtrière Hospital (AP-HP) Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Collegium Medicum University Hospital No. 1 Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Jagiellonianan University, University Hospital Krakow Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Medical University of Warsaw Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Middle-Slovak Institute of Cardiovascular Diseases Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Unknown status |
| Center of Interventional Neuroradiology and Endovascular Treatment Coordinator of this site? Confirm its status | Bratislava | Slovakia | Unknown status |
| Cardiocentre Coordinator of this site? Confirm its status | Nitra | Slovakia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.