Randomized, Open Label Trial of 6 Months Versus 12 Months DAPT After Drug-Eluting Stent in STEMI

NCT ID: NCT01459627

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2017-08-31

Brief Summary

OBJECTIVE OF THE STUDY: To test the hypothesis that 6 months DAPT (Dual anti-platelet therapy) after second generation DES (Drug Eluting Stent) implantation in STEMI (ST elevation Myocardial Infarction) is not inferior to 12 months DAPT in terms of clinical outcomes (composite endpoint of all-cause mortality, any MI, any revascularization, stroke and major bleeding at 18 months after randomization).

The trial will incorporate two registers studying respectively the safety outcomes of Bivalirudin and Prasugrel combination and Bivalirudin and Ticagrelor combination at 2 and 30 days. Finally the trial design permits assessment of the clinical outcomes after primary PCI for treatment of STEMI with the new Resolute Integrity (Medtronic Santa Rosa Ca, USA) stent at 30 days and 6 months.

Detailed Description

BACKGROUND OF THE STUDY: First generation DES (Drug Eluting Stents) have significantly reduced the restenosis rates compared to the BMS (Bare Metal Stents) but have raised concerns regarding higher rates and ongoing propensity for stent thrombosis. Based on these concerns current guidelines advocate dual antiplatelet therapy (DAPT, aspirin plus P2Y12 inhibitor) to be continued for up to 1 year after DES implantation. Large registries analyzing recent data now challenge these recommendations and suggest no increase in mortality or (late) stent thrombosis when DAPT is discontinued after 6 months.

STUDY DESIGN: This is a prospective, randomized, open-label trial testing the hypothesis that 6 months DAPT after second generation drug eluting stent (DES) implantation in STEMI is not inferior to 12 months DAPT in terms of clinical outcomes. Patients with STEMI undergoing primary PCI will be enrolled at presentation. Only those patients who are event-free (death, MI, ST, TVR/TLR or unscheduled revascularization with DES in the first 6 months and stroke or bleeding requiring discontinuation of DAPT) and 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 additional 6 months (up to 12 months after primary PCI) and assessed at 18 months post randomization.

STUDY POPULATION: Patients between 18 and 85 years, presenting with STEMI undergoing PCI with DES implantation.

INTERVENTION: 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 additional 6 months (up to 12 months after primary PCI).

PRIMARY STUDY PARAMETERS/OUTCOME OF THE STUDY:

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 Bivalirudin/Prasugrel and Bivalirudin/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.

Conditions

Myocardial Infarction; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6 months DAPT

Dual antiplatelet therapy consisting of aspirin (ASA) and prasugrel or ticagrelor will be discontinued after randomisation.

Group Type: ACTIVE_COMPARATOR

6 months DAPT

Intervention Type: OTHER

Dual antiplatelet therapy will be stopped at randomisation to the 6 months DAPT group. Patients will be treated from 6 months onwards only with ASA.

12 months DAPT

Dual antiplatelet therapy consisting of aspirin (ASA) and prasugrel or ticagrelor will be continued till 12 months after enrollment in the study

Group Type: ACTIVE_COMPARATOR

12 months DAPT

Intervention Type: OTHER

Dual antiplatelet therapy will be continued till 12 months after enrollment in the study

Interventions

6 months DAPT

Dual antiplatelet therapy will be stopped at randomisation to the 6 months DAPT group. Patients will be treated from 6 months onwards only with ASA.

Intervention Type: OTHER

12 months DAPT

Dual antiplatelet therapy will be continued till 12 months after enrollment in the study

Intervention Type: OTHER

Other Intervention Names

ticagrelor, prasugrel, ASA; ticagrelor, prasugrel, ASA

Eligibility Criteria

Inclusion Criteria

STEMI patients between 18-85 years who underwent primary PCI with DES implantation.

Exclusion Criteria

• Intolerance to Aspirin, Prasugrel, Ticagrelor, Heparin, Bivalirudin, Zotarolimus or Everolimus.
• Known bleeding diathesis or known coagulopathy.
• Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization.
• History of stent thrombosis
• DES in main left coronary artery
• Active bleeding, known bleeding diathesis or known coagulopathy.
• Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization.
• Oral anticoagulant therapy with Coumadin derivates
• Malignancies or other comorbidity with a life expectancy of less than one year or that may result in protocol noncompliance
• Pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)

• 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

Registry

• Intolerance to Prasugrel, Ticagrelor, Bivalirudin.
• Known bleeding diathesis or known coagulopathy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Maasstad Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elvin Kedhi, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Isala

Martin van der Ent, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maasstadhospital / MCR B.V.

Clemens von Birgelen, MD PhD

Role: STUDY_CHAIR

Medisch Spectrum Twente

Felix Zijlstra, MD PhD

Role: STUDY_CHAIR

Erasmus Medisch Centrum

Locations

VU medisch Centrum

Amsterdam, , Netherlands

Amphia ziekenhuis

Breda, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

Atrium MC Parkstad

Heerlen, , Netherlands

Maasstadhospital

Rotterdam, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Haga Hospital

The Hague, , Netherlands

Isala Clinics

Zwolle, , Netherlands

Oslo University Hospital

Oslo, , Norway

Amerykańskie Kliniki Serca

Bielsko-Biala, , Poland

Małopolskie Centrum Sercowo-Naczyniowe PAKS

Chrzanów, , Poland

Polsko-Amerykańskie Kliniki Serca

Dąbrowa Górnicza, , Poland

Polsko_Amerykanskei Kliniki Serca

Kędzierzyn-Koźle, , Poland

University Hospital in Krakow

Krakow, , Poland

Polsko_Amerykanskei Kliniki Serca

Nysa, , Poland

Hôpital Cantonal Fribourg

Fribourg, , Switzerland

Countries

Netherlands; Norway; Poland; Switzerland

References

Kedhi E, Delewi R, Fabris E, De Luca G, Hermanides RS, van den Ent M, Buszman P, Zijlstra F, Song YB, Gwon HC, Hahn JY. Duration of dual antiplatelet therapy after myocardial infarction: Insights from a pooled database of the SMART-DATE and DAPT-STEMI trials. Atherosclerosis. 2020 Dec;315:55-61. doi: 10.1016/j.atherosclerosis.2020.11.003. Epub 2020 Nov 9.

Reference Type: DERIVED

PMID: 33227548 (View on PubMed)

Postma W, Fabris E, Van der Ent M, Hermanides R, Buszman P, Von Birgelen C C, Cook S, Wedel H, De Luca G, Delewi R, Zijlstra F, Kedhi E. Resolute zotarolimus-eluting stent in ST-elevation myocardial infarction (resolute-STEMI): A prespecified prospective register from the DAPT-STEMI trial. Catheter Cardiovasc Interv. 2020 Mar 1;95(4):706-710. doi: 10.1002/ccd.28376. Epub 2019 Jul 3.

Reference Type: DERIVED

PMID: 31268629 (View on PubMed)

Kedhi E, Fabris E, van der Ent M, Buszman P, von Birgelen C, Roolvink V, Zurakowski A, Schotborgh CE, Hoorntje JCA, Eek CH, Cook S, Togni M, Meuwissen M, van Royen N, van Vliet R, Wedel H, Delewi R, Zijlstra F. Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial. BMJ. 2018 Oct 2;363:k3793. doi: 10.1136/bmj.k3793.

Reference Type: DERIVED

PMID: 30279197 (View on PubMed)

Other Identifiers

DAPT-STEMI

Identifier Type: -

Identifier Source: org_study_id