Prospective, randomized, open label trial of six vs. twelve months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction.

Prospective, randomized, open label trial of six vs. twelve months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction. - DAPT-STEMI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39800

Enrollment

580

Registered

2011-08-15

Start date

2011-12-20

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DAPT treatment after PCI Dual-antiplatelettherapy after stent implantation

Interventions

Patients, who are event-free and stil on DAPT at 6 months after primary PCI will be randomized (1:1 fashion) between single (aspirin) versus dual antiplatelet therapy (aspirin plus P2Y12) for an add

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: STEMI patients between 18-85 years, who underwent PCI with second generation DES implantation

Exclusion criteria

Exclusion criteria: Key Exclusion Criteria Enrollment: Intolerance to Aspirin, Plasugrel, Ticagrelor, Heparin, Bivaluridin, Everoliumus or Zotarolimus. Known bleeding diathesis or known coagulopathy. Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization.;Key Exclusion Criteria Randomization: Occurrence of death, myocardial infarction, stent thrombosis and target vessel or lesion revascularization during the first 6 months after inclusion. Stroke or bleeding requiring discontinuation of DAPT during the first 6 months after inclusion. Oral anticoagulant therapy with coumarin derivates.

Design outcomes

Primary

Measure	Time frame
DAPT STEMI trial Composite endpoint of all cause mortality, any MI, any revascularization, stroke, ST and Bleeding (TIMI) (net MACCE) at 18 months after randomization Registry Bivilarudine/Prasugrel and Bivlarudine/Ticagrelor All cause mortality, MI, Stroke, ST and bleeding (following BARC) at 2 and 30 days. Report Resolute Integrity Primary endpoint of DAPT-STEMI, at 30 days and 6 months.	—

Secondary

Measure	Time frame
DAPT-STEMI trial • All cause mortality, any MI, stroke, stent thrombosis (ST) and major bleeding (TIMI) at 9 and 18 months after randomization • ST definite/probable academic research consortium (ARC) definition at 9, and 18 months post randomization • All cause mortality at 9 and 18 months after randomization • Cardiac mortality at 9 and 18 months after randomization • Any MI at 9 and 18 months after randomization • Target vessel MI at 9 and 18 months after randomization • Bleeding at 9 and 18 months after randomization • Stroke at 9 and 18 months after randomization • Target vessel revascularization (TVR) at 9 and 18 months after randomization • Target lesion revascularization (TLR) at 9 and 18 months after randomization • Target vessel failure (TVF) at 9 and 18 months after randomization. • Target lesion failure (TLF), at 9 and 18 months after randomization Registry • ST following ARC definition at 2 and 30 days. • All cause mortality at 2 and 30 days. • Cardiac mortality at 2 and 30 days. • All MI at 2 and 30 days. • Target vessel MI at 2 and 30 days. • Bleeding (BARC) at 2 days. • Stroke at 2 days. Report Resolute Integrity • Identical to DAPT-STEMI, at 30 days and 6 months	—

Measure

Time frame

DAPT-STEMI trial • All cause mortality, any MI, stroke, stent thrombosis (ST) and major bleeding (TIMI) at 9 and 18 months after randomization • ST definite/probable academic research consortium (ARC) definition at 9, and 18 months post randomization • All cause mortality at 9 and 18 months after randomization • Cardiac mortality at 9 and 18 months after randomization • Any MI at 9 and 18 months after randomization • Target vessel MI at 9 and 18 months after randomization • Bleeding at 9 and 18 months after randomization • Stroke at 9 and 18 months after randomization • Target vessel revascularization (TVR) at 9 and 18 months after randomization • Target lesion revascularization (TLR) at 9 and 18 months after randomization • Target vessel failure (TVF) at 9 and 18 months after randomization. • Target lesion failure (TLF), at 9 and 18 months after randomization Registry • ST following ARC definition at 2 and 30 days. • All cause mortality at 2 and 30 days. • Cardiac mortality at 2 and 30 days. • All MI at 2 and 30 days. • Target vessel MI at 2 and 30 days. • Bleeding (BARC) at 2 days. • Stroke at 2 days. Report Resolute Integrity • Identical to DAPT-STEMI, at 30 days and 6 months

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)