Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction
NCT ID: NCT05262803
Last Updated: 2024-03-15
Study Results
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Basic Information
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RECRUITING
PHASE4
2808 participants
INTERVENTIONAL
2022-06-17
2028-12-31
Brief Summary
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Aim: The aim of this trial is to assess a reduced antithrombotic strategy for high bleeding risk patients with heart attacks to reduce bleeding safely.
Hypothesis: Significantly reduced bleeding with a similar preventive effect are expected.
Design: The Dan-DAPT trial include high bleeding risk patients with heart attacks from Danish hospitals (Rigshospitalet, Aarhus, Odense, Aalborg, Roskilde, and Gentofte hospital) and randomize them to standard-of-care or shorter and individualized antithrombotic therapy based on responsiveness to clopidogrel after genetic testing.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard-of-care DAPT
Dual antiplatelet therapy (DAPT) with acetylsalicylic acid (ASA) and prasugrel or ticagrelor for 6 months followed by ASA monotherapy.
No interventions assigned to this group
Genotype-guided DAPT
DAPT according to CYP2C19\*2/\*3-genotyping for 6 months followed by ASA monotherapy.
CYP2C19*2/*3
* Non-carriers of CYP2C19\*2/\*3 loss-of-function alleles: DAPT with clopidogrel and ASA
* Carriers of CYP2C19\*2/\*3 loss-of-function alleles: DAPT with prasugrel (or ticagrelor) and ASA
Shorter genotype-guided DAPT
DAPT according to CYP2C19\*2/\*3-genotyping for 3 months followed by ASA monotherapy.
CYP2C19*2/*3
* Non-carriers of CYP2C19\*2/\*3 loss-of-function alleles: DAPT with clopidogrel and ASA
* Carriers of CYP2C19\*2/\*3 loss-of-function alleles: DAPT with prasugrel (or ticagrelor) and ASA
Shorter DAPT duration
Duration of DAPT is shortened to 3 months
Interventions
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CYP2C19*2/*3
* Non-carriers of CYP2C19\*2/\*3 loss-of-function alleles: DAPT with clopidogrel and ASA
* Carriers of CYP2C19\*2/\*3 loss-of-function alleles: DAPT with prasugrel (or ticagrelor) and ASA
Shorter DAPT duration
Duration of DAPT is shortened to 3 months
Eligibility Criteria
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Inclusion Criteria
* symptoms indicating acute myocardial ischemia
* new ischemic changes on the electrocardiogram
* development of pathological Q-waves
* imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
* visible coronary thrombus by angiography
2. PRECISE-DAPT score ≥25
3. Age ≥18 years
Exclusion Criteria
2. Indication for oral anticoagulation
3. Previous stent thrombosis
4. Life expectancy \<1 year
5. Resuscitated cardiac arrest with Glasgow Coma Scale \<8 and/or need of intubation
6. Prior intracranial hemorrhage
7. Active bleeding (BARC ≥2) at randomization
8. Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception
9. Hypertensive crisis (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg)
10. Unable to understand and follow study-related instructions or to comply with study protocol
18 Years
ALL
No
Sponsors
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Rikke Sorensen
OTHER
Responsible Party
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Rikke Sorensen
MD, Ph.D.
Locations
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Aalborg University Hospital
Aalborg, , Denmark
The Heart Centre, Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Herlev and Gentofte University Hospital - Gentofte
Hellerup, , Denmark
Odense University Hospital
Odense, , Denmark
Zealand University Hospital
Roskilde, , Denmark
Aarhus University Hospital
Skejby, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Phillip Freeman, BSc, MBBS, MRCP, Ph.D.
Role: primary
Mette G Charlot, MD, Ph.D.
Role: primary
Karsten T Veien, MD, DMSc
Role: primary
Henning S Kelbaek, MD, DMSc
Role: primary
Erik L Grove, Assoc.prof., MD, Ph.D.
Role: primary
References
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Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):34-78. doi: 10.1093/ejcts/ezx334. No abstract available.
Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.
Costa F, van Klaveren D, James S, Heg D, Raber L, Feres F, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Zanchin T, Palmerini T, Wallentin L, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M; PRECISE-DAPT Study Investigators. Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet. 2017 Mar 11;389(10073):1025-1034. doi: 10.1016/S0140-6736(17)30397-5.
Claassens DMF, Vos GJA, Bergmeijer TO, Hermanides RS, van 't Hof AWJ, van der Harst P, Barbato E, Morisco C, Tjon Joe Gin RM, Asselbergs FW, Mosterd A, Herrman JR, Dewilde WJM, Janssen PWA, Kelder JC, Postma MJ, de Boer A, Boersma C, Deneer VHM, Ten Berg JM. A Genotype-Guided Strategy for Oral P2Y12 Inhibitors in Primary PCI. N Engl J Med. 2019 Oct 24;381(17):1621-1631. doi: 10.1056/NEJMoa1907096. Epub 2019 Sep 3.
Jacobsen MR, Engstrom T, Torp-Pedersen C, Gislason G, Glinge C, Butt JH, Fosbol EL, Holmvang L, Pedersen F, Kober L, Jabbari R, Sorensen R. Clopidogrel, prasugrel, and ticagrelor for all-comers with ST-segment elevation myocardial infarction. Int J Cardiol. 2021 Nov 1;342:15-22. doi: 10.1016/j.ijcard.2021.07.047. Epub 2021 Jul 24.
Jacobsen MR, Jabbari R, Grove EL, Maeng M, Veien K, Hougaard M, Freeman P, Kelbaek H, Charlot MG, Engstrom T, Sorensen R. Genotype-guided de-escalation and abbreviation of dual antiplatelet therapy in patients with myocardial infarction and high bleeding risk: Design and rationale of the investigator-initiated, multicenter, randomized, controlled trial, DAN-DAPT. Am Heart J. 2025 Jul;285:74-81. doi: 10.1016/j.ahj.2025.02.020. Epub 2025 Feb 26.
Other Identifiers
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2022-500125-32-00
Identifier Type: -
Identifier Source: org_study_id
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