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. 2025 Jul:285:74-81.
doi: 10.1016/j.ahj.2025.02.020. Epub 2025 Feb 26.

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

Mia Ravn Jacobsen  1 , Reza Jabbari  2 , Erik Lerkevang Grove  3 , Michael Mæng  4 , Karsten Veien  5 , Mikkel Hougaard  5 , Philip Freeman  6 , Henning Kelbæk  7 , Mette Gitz Charlot  2 , Thomas Engstrøm  2 , Rikke Sørensen  2
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Free article

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

Mia Ravn Jacobsen et al. Am Heart J. 2025 Jul.
Free article

Abstract

Rationale: Approximately one-third of patients with myocardial infarction (MI) treated with percutaneous coronary intervention (PCI) are at high risk of bleeding side-effects when on dual antiplatelet therapy (DAPT). High bleeding risk is often accompanied by high ischemic risk, thus challenging the choice of P2Y12 inhibitor and duration of DAPT. The optimal DAPT strategy for these patients remains debated, and it is unknown whether genotype-guided DAPT de-escalation to clopidogrel and aspirin, with or without abbreviation of DAPT to 3 months, is noninferior in terms of net adverse clinical events (NACE) and superior in reducing bleeding side-effects compared with standard DAPT for 6 months.

Design: The DAN-DAPT trial is an investigator-initiated, open-label, multicenter, multiarm, randomized controlled trial conducted at all Danish hospitals performing PCI. From 2022 to 2029, we planned to randomize 2,700 patients with MI and high bleeding risk in a 1:1:1 ratio to 1 of 3 groups: CYP2C19-genotyping and 6 months DAPT (experimental group 1), CYP2C19-genotyping and 3 months DAPT (experimental group 2), and 6 months DAPT with prasugrel (or ticagrelor) and aspirin (control group). The coprimary outcomes are NACE defined as the composite of all-cause mortality, recurrent MI, definite stent thrombosis, stroke, and BARC type 3-5 bleeding (Bleeding Academic Research Consortium), and major and minor bleedings defined as the composite of BARC type 2-5 bleedings at 1 year.

Conclusion: DAN-DAPT trial is an open-label, multicenter, randomized controlled trial comparing genotype-guided DAPT de-escalation to clopidogrel - with or without DAPT abbreviation to 3 months - and standard DAPT for 6 months after PCI in high bleeding risk patients with MI. As of March 2025, 36% of the planned 2,700 patients have been enrolled in the study.

Trial registration: ClincialTrials.gov (NCT05262803) and EU number (2022-500125-32-00).

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Conflict of interest statement

Conflict of interest None related to the DAN-DAPT trial. Outside the submitted work, the authors declare the following: RZ has received speaker honoraria from Bristol-Myers Squibb. ELG has received speaker honoraria or consultancy fees from AstraZeneca, Bayer, Bristol-Myers Squibb, Pfizer, Novo Nordisk, Lundbeck Pharma and Organon. He is investigator in clinical studies sponsored by AstraZeneca, Idorsia or Bayer and has received unrestricted research grants from Boehringer Ingelheim. MM is supported by a grant from the Novo Nordisk Foundation (grant number NNF22OC0074083); has received lecture and/or advisory board fees from AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, and Novo Nordisk, has received a travel grant from Novo Nordisk, has received institutional research grants from Philips, Bayer and Novo Nordisk, has ongoing research contracts with Janssen, Novo Nordisk, and Philips, and equity in Novo Nordisk, Eli Lilly & Company, and Verve Therapeutics. MGC has received speaker honoraria from Abbott and Novo Nordisk. TE has received speaker honoraria or consultancy fees from Bayer, Novo Nordisk, and Abbott. He is investigator in clinical studies sponsored by Novo Nordisk. RS has received Institutional Research Grant from Novo Nordisk Foundation, speaker honoraria from Bayer, Bristol-Myers Squibb, and Astra Zeneca, and fees from Novo Nordisk for work in data safety and monitoring board (not related to this work).

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