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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Maasstad Hospital
ClinicalTrials.gov Identifier:
NCT01459627
First received: October 18, 2011
Last updated: September 9, 2015
Last verified: September 2015
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Cardiovascular Disease
Other: 6 months DAPT
Other: 12 months DAPT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Open Label Trial of 6 Months vs. 12 Months Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Maasstad Hospital:

Primary Outcome Measures:
  • Net MACCE [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • All cause mortality, MI, Stroke, ST and bleeding [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Primary outcome of Registry: All cause mortality, MI, Stroke, ST and Bleeding(following BARC)at 2 days.

  • All cause mortality, MACCE, TIMI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: All cause mortality, any MI, stroke, stent thrombosis (ST) and major bleeding (TIMI) at 9 months after randomization

  • ST definite/probable [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: ST definite/probable academic research consortium (ARC) definition at 9 months post randomization.

  • all cause mortality [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: All cause mortality at 9 months after randomization.

  • Cardiac mortality [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Cardiac mortality at 9 months after randomization.

  • MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Any MI at 9 months after randomization.

  • Target vessel MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Target vessel MI at 9 months after randomization.

  • Bleeding [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Bleeding at 9 months after randomization.

  • stroke [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Stroke at 9 months after randomization.

  • Target vessel revascularization [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Target vessel revascularization (TVR) at 9 months after randomization.

  • Target lesion revascularization [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Target lesion revascularization (TLR) at 9 months after randomization.

  • Target vessel failure [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT STEMI: Target vessel failure (TVF) at 9 months after randomization.

  • Target lesion failure [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Target lesion failure (TLF), at 9 months after randomization.

  • net MACCE [ Time Frame: 30days ] [ Designated as safety issue: Yes ]

    Primary endpoint of Report Resolute Integrity: Composite endpoint of all cause mortality, any myocardial infarction (MI) , any revascularization, stroke and major bleeding (TIMI) (net MACCE) at 30 days after randomization.

    Secondary endpoints of Report Resolute Integrity: Secondary endpoints of DAPT-STEMI at 30 days.


  • All cause mortality, MI, Stroke, ST and bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Primary outcome of registry: All cause mortality, MI,Stroke, ST and Bleeding (following BARC) at 30 days.

  • net MACCE [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    Primary endpoint of Report Resolute Integrity: Composite endpoint of all cause mortality, any myocardial infarction (MI) , any revascularization, stroke and major bleeding (TIMI) (net MACCE) at 6 months after randomization.

    Secondary endpoints of Report Resolute Integrity: Secondary endpoints of DAPT-STEMI at 6 monthss.


  • All cause mortality, MACCE, TIMI [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: All cause mortality, any MI, stroke, stent thrombosis (ST) and major bleeding (TIMI) at 18 months after randomization

  • ST definite/probable [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: ST definite/probable academic research consortium (ARC) definition at 18 months post randomization.

  • All cause mortality [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: All cause mortality at 18 months after randomization.

  • Cardiac mortality [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Cardiac mortality at 18 months after randomization.

  • MI [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Any MI at 18 months after randomization.

  • Target vessel MI [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Target vessel MI at 18 months after randomization.

  • Bleeding [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Bleeding at 18 months after randomization.

  • Stroke [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Stroke at 18 months after randomization.

  • Target vessel revascularization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Target vessel revascularization (TVR) at 18 months after randomization.

  • Target lesion revascularization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Target lesion revascularization (TLR) at 18 months after randomization.

  • Target vessel failure [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT STEMI: Target vessel failure (TVF) at 18 months after randomization.

  • Target lesion failure [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    DAPT-STEMI: Target lesion failure (TLF), at 18 months after randomization.

  • ST following ARC [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Registry: ST following ARC definition at 2 days

  • ST following ARC [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Registry: ST following ARC definition at 30 days

  • All cause mortality [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Registry: All cause mortality at 2 days

  • All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Registry: All cause mortality at 30 days

  • Cardiac mortality [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Registry: Cardiac Mortality at 2 days

  • Cardiac Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Registry: Cardiac Mortality at 30 days

  • All MI [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Registry: All MI at 2 days.

  • All MI [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Registry: All MI at 30 days.

  • Target vessel MI [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Registry: Target vessel MI at 2 days.

  • Target vessel MI [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Registry: Target vessel MI at 30 days.

  • Bleeding BARC [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Registry: Bleeding (BARC) at 2 days

  • Bleeding (BARC) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Registry: Bleeding (BARC) at 30 days

  • Stroke [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Registry: Stroke at 2 days


Estimated Enrollment: 1100
Study Start Date: December 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 6 months DAPT
Dual antiplatelet therapy consisting of aspirin (ASA) and prasugrel or ticagrelor will be discontinued after randomisation.
Other: 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.
Other Name: ticagrelor, prasugrel, ASA
Active Comparator: 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
Other: 12 months DAPT
Dual antiplatelet therapy will be continued till 12 months after enrollment in the study
Other Name: ticagrelor, prasugrel, ASA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion criteria enrolment:

  • 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)

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

Registry

Exclusion criteria

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

Report Resolute Integrity Exclusion criteria

• See exclusion criteria enrollment DAPT-STEMI protocol

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459627

Locations
Netherlands
VU medisch Centrum
Amsterdam, Netherlands, 1081 HV
Amphia ziekenhuis
Breda, Netherlands, 4818CK
Haga Hospital
Den Haag, Netherlands, 2512VA
Medisch Spectrum Twente
Enschede, Netherlands
Atrium MC Parkstad
Heerlen, Netherlands
Erasmus MC
Rotterdam, Netherlands
Maasstadhospital
Rotterdam, Netherlands, 3079DZ
Isala Clinics
Zwolle, Netherlands
Norway
Oslo University Hospital
Oslo, Norway
Poland
Amerykańskie Kliniki Serca
Bielsko-Biala, Poland, 43316
Małopolskie Centrum Sercowo-Naczyniowe PAKS
Chrzanów, Poland, 32500
Polsko-Amerykańskie Kliniki Serca
Dąbrowa Górnicza, Poland, 41300
Polsko_Amerykanskei Kliniki Serca
Kedzierzyn Kozle, Poland
University Hospital in Krakow
Krakow, Poland
Polsko_Amerykanskei Kliniki Serca
Nysa, Poland
Switzerland
Hôpital Cantonal Fribourg
Fribourg, Switzerland, 1708
Sponsors and Collaborators
Maasstad Hospital
Medtronic
Investigators
Principal Investigator: Elvin Kedhi, MD PHD Isala
Principal Investigator: Martin van der Ent, MD PhD Maasstadhospital / MCR B.V.
Study Chair: Clemens von Birgelen, MD PhD Medisch Spectrum Twente
Study Chair: Felix Zijlstra, MD PhD Erasmus Medisch Centrum
  More Information

Responsible Party: Maasstad Hospital
ClinicalTrials.gov Identifier: NCT01459627     History of Changes
Other Study ID Numbers: DAPT-STEMI 
Study First Received: October 18, 2011
Last Updated: September 9, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Regional Ethical Review Board
Norway: Ethics Committee
Switzerland: Ethikkommission
Poland: Ethics Committee

Keywords provided by Maasstad Hospital:
DAPT- Dual Antiplatelet Therapy
STEMI

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Ticagrelor
Prasugrel Hydrochloride
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on July 21, 2016