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

NCT01459627 | Completed Phase 4 DMC

• 1 other identifier: DAPT-STEMI
• Study Type: interventional
• Target: 1,100
• Locations: 4 countries
• Sites: 16

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.

Conditions

Myocardial Infarction; Cardiovascular Disease

Keywords

DAPT- Dual Antiplatelet Therapy; STEMI

Outcome Measures

Primary Outcomes (1)

• Net MACCE

  DAPT-STEMI trial: Composite endpoint of all cause mortality, any myocardial infarction (MI) , any revascularization, stroke and major bleeding (TIMI) (net MACCE) at 18 months after randomization

  18 months

Secondary Outcomes (41)

• All cause mortality, MI, Stroke, ST and bleeding

  2 days

• All cause mortality, MACCE, TIMI

  9 months

• ST definite/probable

  9 months

• all cause mortality

  9 months

• Cardiac mortality

  9 months

Study Arms (2)

6 months DAPT

ACTIVE COMPARATOR

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

Other: 6 months DAPT

12 months DAPT

ACTIVE COMPARATOR

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

Other: 12 months DAPT

Interventions

6 months DAPT 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.

Also known as: ticagrelor, prasugrel, ASA

6 months DAPT

12 months DAPT OTHER

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

Also known as: ticagrelor, prasugrel, ASA

12 months DAPT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• Oral anticoagulant therapy
• Registry
• Intolerance to Prasugrel, Ticagrelor, Bivalirudin.
• Known bleeding diathesis or known coagulopathy

Sponsors & Collaborators

• Maasstad Hospital: lead
• Medtronic: collaborator

Study Sites (16)

VU medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

Amphia ziekenhuis

Breda, 4818CK, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Atrium MC Parkstad

Heerlen, Netherlands

Location

Maasstadhospital

Rotterdam, 3079DZ, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Haga Hospital

The Hague, 2512VA, Netherlands

Location

Isala Clinics

Zwolle, Netherlands

Location

Oslo University Hospital

Oslo, Norway

Location

Amerykańskie Kliniki Serca

Bielsko-Biala, 43316, Poland

Location

Małopolskie Centrum Sercowo-Naczyniowe PAKS

Chrzanów, 32500, Poland

Location

Polsko-Amerykańskie Kliniki Serca

Dąbrowa Górnicza, 41300, Poland

Location

Polsko_Amerykanskei Kliniki Serca

Kędzierzyn-Koźle, Poland

Location

University Hospital in Krakow

Krakow, Poland

Location

Polsko_Amerykanskei Kliniki Serca

Nysa, Poland

Location

Hôpital Cantonal Fribourg

Fribourg, 1708, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 33227548 DERIVED

• 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.

  PMID: 31268629 DERIVED

• 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.

  PMID: 30279197 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Cardiovascular Diseases; ST Elevation Myocardial Infarction

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine; Ticagrelor; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Elvin Kedhi, MD PHD

  Isala

  PRINCIPAL INVESTIGATOR

• Martin van der Ent, MD PhD

  Maasstadhospital / MCR B.V.

  PRINCIPAL INVESTIGATOR

• Clemens von Birgelen, MD PhD

  Medisch Spectrum Twente

  STUDY CHAIR

• Felix Zijlstra, MD PhD

  Erasmus Medisch Centrum

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 25, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 7, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); NO (1); NL (8); PL (6)