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Acute Myocardial InfarctionPhase 4DAPT-SHOCK-AMINCT03551964

Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction

A Phase 4 study testing Cangrelor and Ticagrelor in people with Acute Myocardial Infarction and Cardiogenic Shock, run by Faculty Hospital Kralovske Vinohrady at 29 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cangrelor and Ticagrelor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
605 participants
Where
29 sitesin 5 countries
Study dates
1 Aug 2018to 1 Apr 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

29 sites in 5 countries.

29 sites in 5 countries

Czechia18 sites

  • St. Anne's University Hospital Brno

    Brno, 656 91

  • Department of Cardiology, University Hospital Brno-Bohunice

    Brno

  • Cardiology Department, Regional Hospital

    České Budějovice

  • University Hospital Hradec Králové

    Hradec Králové, 500 05

  • Cardiology department, Regional hospital

    Jihlava

  • Cardiocenter, Regional Hospital

    Karlovy Vary

  • Krajská nemocnice Liberec

    Liberec, 460 63

  • University Hospital Olomouc

    Olomouc, 77900

  • University Hospital Ostrava

    Ostrava, 70852

  • Department of Cardiology, Regional Hospital,

    Pardubice

  • University Hospital Pilsen

    Pilsen, 304 60

  • University Hospital Kralovske Vinohrady

    Prague, Please Select, 10034

  • General University Hospital in Prague

    Prague, 12808

  • Institute of Clinical and Experimental Medicine

    Prague, 14021

  • Na Homolce Hospital

    Prague, 150 30

  • Cardiocenter, Hospital Podlesi

    Třinec

  • Masaryk Hospital

    Ústí nad Labem, 40011

  • Regional Hospital T. Bati

    Zlín, 762 75

Other trials in Czechia

Germany3 sites

  • Heart Center Freiburg University

    Freiburg im Breisgau

  • University Medical Centre

    Mannheim

  • University Hospital Tübingen

    Tübingen, 72076

Other trials in Germany

Poland3 sites

  • Collegium Medicum University Hospital No. 1

    Bydgoszcz

  • Jagiellonianan University, University Hospital Krakow

    Krakow

  • Medical University of Warsaw

    Warsaw

Other trials in Poland

Slovakia3 sites

  • Middle-Slovak Institute of Cardiovascular Diseases

    Banská Bystrica

  • Center of Interventional Neuroradiology and Endovascular Treatment

    Bratislava

  • Cardiocentre

    Nitra

Other trials in Slovakia

France2 sites

  • Département de Cardiologie, Hôpital Bichat Assistance Publique Hôpitaux de Paris

    Paris

  • Pitié-Salpêtrière Hospital (AP-HP)

    Paris

Other trials in France

About this study

Official title: Cangrelor Versus Ticagrelor In Patients With Acute Myocardial Infarction Complicated With Initial Cardiogenic Shock

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.

Read the detailed description

Randomization to study drugs will be performed using an online database system for data collection. After entering basic patient data, the assigned arm and the randomization code will be generated based on a predefined randomization scheme.

Concomitant therapy includes acetylsalicylic acid: an initial intravenous dose of 500 mg, followed by a daily oral dose of 100 mg. A proton pump inhibitor is also recommended. Additional therapies, such as further antithrombotic treatments (e.g., GP IIb/IIIa inhibitors, heparin) and mechanical support (IABP, ECMO), remain fully within the competence of the treating physician.

Electronic database - eCRF. The data from individual follow-up assessments will be entered into an electronic database. The online instrument CLADE-IS will be used for data collection; this instrument provides robust options for electronic case report form (eCRF) design, hierarchical administration of user rights and a user-friendly web interface. The system provides predefined validation rules, conversions of variables, and it considers the relationships between variables; user access is controlled by the hierarchical system of user rights and user roles, and database operations are stored for audits and tracking of changes. Data safety is ensured through physical security of the servers, authorized access, and backup procedures.

Laboratory collections. The efficacy of the antiplatelet drugs cangrelor and ticagrelor will be determined using flow cytometry analysis of intracellular VASP (vasodilator-stimulated phosphoprotein) phosphorylation.

Study Committees: Executive c., Steering c., Endpoint adjudication c., Data safety monitoring board.

Monitoring. External monitor Clinical Research Associate (CRA)

Definitions.

Death is defined as death from all causes.

Death from cardiovascular causes is defined as a death with evidence of a cardiovascular cause or any death without clear evidence of a non-cardiovascular cause. All deaths are considered cardiac unless a clear non-cardiac cause can be identified. Any unexpected death (for example, in patients with a co-existing, potentially fatal non-cardiac disease such as cancer or infection) is classified as a death from cardiovascular causes.

Myocardial reinfarction (MI) is defined as a new (additional) MI that must differ from the MI based on which the patient was enrolled into the study, satisfying the universal definition of MI criteria.

Urgent revascularization of the infarct-related artery is defined as a new emergent/urgent revascularization of the artery that was intervened in during the initial procedure due to repeated manifestations of ischemia after the completion of the initial PCI.

Stroke is defined as the rapid onset of a new neurological deficit due to an ischemic or hemorrhagic lesion in the central nervous system, with symptoms lasting at least 24 hours from their onset or resulting in death.

Definitive stent thrombosis is defined according to the Academic Research Consortium criteria.

New heart failure is defined as a hospitalization or emergency check-up for heart failure in a doctor's office or emergency room that requires treatment.

Bleeding is defined according to the Bleeding Academic Research Consortium (BARC) criteria.

External collaborating centre for data-management and statistical analyses: Institute of Biostatistics and Analyses at the Faculty of Medicine of the Masaryk University in Brno, Czech Republic.

Being tested
Cangrelor, Ticagrelor
Keywords
Acute myocardial infarction, Cardiogenic shock, Primary percutaneous coronary intervention, Dual antiplatelet therapy, Cangrelor, Ticagrelor
Medical subject headings
Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CangrelorDrug

    Also called intravenous P2Y12 inhibitor

    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.

  • TicagrelorDrug

    Also called oral P2Y12 inhibitor

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

Study groups in NCT03551964
Study groupRoleWhat they receive
Cangrelor therapyExperimentalIV Cangrelor is initiated immediately after the patient arrives at the 24/7 PCI center (cathlab, coronary/intensive care unit, other parts of department) and is randomized to the study.
Receives: Drug: Cangrelor
Ticagrelor therapyActive comparatorThe patient will receive the initial dose of crushed Ticagrelor immediately after arriving at the 24/7 PCI center (cath lab, coronary/intensive care unit, other parts of the department) and after being randomly assigned to the study; in patients with a disorder of consciousness, the initial dose will be administered immediately after the nasogastric tube is inserted.
Receives: Drug: Ticagrelor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Laboratory endpoint

    The periprocedural rate of onset and the proportion of patients who achieve effective* P2Y12 platelet receptor inhibition defined by a Platelet Reactivity Index (PRI) value.

    *PRI less than 50% as measured by the vasodilator-stimulated phosphoprotein phosphorylation flow cytometric assay

    Measured: At the end of primary percutaneous coronary intervention; Within 24 hours from randomization

  2. Primary Clinical Endpoint

    The composite of all-cause death, myocardial infarction, or ischemic stroke expressed as a proportion of patients with any of these events.

    Measured: Within 30 days after randomization

Secondary outcomes (14)

  1. Key secondary efficacy endpoint

    Death, myocardial infarction, urgent revascularization of the infarct-related artery, stent thrombosis, or ischemic stroke expressed as a proportion of patients with any of these events

    Measured: Within 30 days and one year after randomization

  2. Key secondary safety endpoint

    Bleeding as defined by BARC type ≥ 3B, expressed as a proportion of patients with this event.

    Measured: Within 30 days and one year after randomization

  3. Secondary net-clinical endpoint

    Death, myocardial infarction, urgent revascularization of the infarct-related artery, stroke, or major bleeding as defined by the BARC type ≥ 3B criteria expressed as a proportion of patients with any of these events.

    Measured: Within 30 days and one year after randomization

  4. Secondary efficacy endpoint

    Cardiovascular death, myocardial infarction, urgent revascularization, and heart failure expressed as a proportion of patients with any of these events.

    Measured: Within 30 days and one year after randomization

  5. Secondary endpoint

    Heart failure, expressed as a proportion of patients with this event.

    Measured: Within 30 days and one year after randomization

  6. Other secondary outcome

    Individual components of the primary clinical endpoint.

    Measured: Within 30 days and one year after randomization

  7. Other secondary efficacy endpoint

    Death from cardiovascular causes, expressed as a proportion of patients with this event.

    Measured: Within 30 days and one year after randomization

  8. Other secondary endpoint

    Definite stent thrombosis, expressed as a proportion of patients with this event.

    Measured: Within 30 days after randomization

  9. Secondary safety endpoint

    Bleeding as defined by BARC type ≥ 3B, expressed as a proportion of patients with this event.

    Measured: Within 30 days after randomization

  10. Other secondary outcome

    Delayed* aortocoronary bypass surgery due to a risk of bleeding.

    *Assessed by the heart team, indicating aortocoronary bypass surgery.

    Measured: Within 30 days after randomization

  11. Secondary laboratory endpoint

    Effective* P2Y12 platelet receptor inhibition defined by Platelet Reactivity Index (PRI) value

    *PRI less than 50% as measured by the vasodilator-stimulated phosphoprotein phosphorylation flow cytometric assay

    Measured: 1 hour after primary PCI

  12. Secondary endpoint

    Duration of hospitalization* in days

    *Intensive care unit stay and total hospital stay

    Measured: From randomization to end of index event hospitalization, within 3 months after randomization

  13. Other secondary endpoint

    Maximum values of high-sensitive cardiac troponin in μg per liter

    Measured: Initial phase of index event hospitalization, within 7 days after randomization

  14. Secondary outcome

    Duration of vasoactive pharmacotherapy and/or mechanical circulatory support in days

    Measured: From randomization to the end of vasoactive pharmacotherapy / mechanical circulatory support, within 30 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2018
  2. Study start1 Aug 2018
  3. Primary completion19 Feb 2024
  4. Study completion1 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
605 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03551964
Sponsor's protocol ID
13062017-23-1
Other IDs
2018-002161-19, 2018
Acronym
DAPT-SHOCK-AMI
Status last verified
Apr 2025
First submitted
29 May 2018
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Motovska Z, Hlinomaz O, Mrozek J, Kala P, Geisler T, Hromadka M, Akin I, Precek J, Kettner J, Cervinka P, Montalescot G, Jarkovsky J, Belohlavek J, Bis J, Matejka J, Vodzinska A, Muzafarova T, Tomasov P, Schee A, Bartus S, Andrasova A, Olivier CB, Kovarik A, Ostadal P, Demlova R, Souckova L, Vulev I, Coufal Z, Kochman J, Marinov I, Kubica J, Ducrocq G, Karpisek M, Klimsa Z, Hudec M, Widimsky P, Bhatt DL, Group DS. Cangrelor versus crushed ticagrelor in patients with acute myocardial infarction and cardiogenic shock: rationale and design of the randomised, double-blind DAPT-SHOCK-AMI trial. EuroIntervention. 2024 Oct 21;20(20):e1309-e1318. doi: 10.4244/EIJ-D-24-00203.

    PubMed 39432252

  • Filipescu R, Collins SP, Radu RI, Ben Gal T, Antohi L, Abdelhamid M, Geavlete O, Pana M, Farmakis D, Matei DC, Savarese G, Margineanu C, Polovina M, Miro O, Guz D, Palazzuoli A, Masip J, Adamo M, Ambrosy AP, Chioncel O. Therapeutic Advances in the Management of Cardiogenic Shock. Am J Ther. 2026 Mar-Apr 01;33(2):e132-e145. doi: 10.1097/MJT.0000000000002025. Epub 2026 Jan 15.

    PubMed 41543923

  • Connery A, Ahuja T, Katz A, Arnouk S, Zhu E, Papadopoulos J, Rao S, Merchan C. Antithrombotic Stewardship: Evaluation of Platelet Reactivity-Guided Cangrelor Dosing Using the VerifyNow Assay. J Cardiovasc Pharmacol. 2024 May 1;83(5):482-489. doi: 10.1097/FJC.0000000000001543.

    PubMed 38335531

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cangrelor and Ticagrelor in people with Acute Myocardial Infarction and Cardiogenic Shock, run by Faculty Hospital Kralovske Vinohrady at 29 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Czechia, Germany, Poland, Slovakia, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Laboratory endpoint (time frame: At the end of primary percutaneous coronary intervention; Within 24 hours from randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03551964, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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