Randomized, Open Label Trial of 6 Months Versus 12 Months DAPT After Drug-Eluting Stent in STEMI
Condition: Myocardial Infarction; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): 6 months DAPT; 12 months DAPT
Intervention type(s): Other; Other
Intervention description(s): 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.; Dual antiplatelet therapy will be continued till 12 months after enrollment in the study
Other intervention name(s): ticagrelor, prasugrel, ASA; ticagrelor, prasugrel, ASA
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DAPT- Dual Antiplatelet Therapy; STEMI