Randomized, Open Label Trial of 6 Months Versus 12 Months DAPT After Drug-Eluting Stent in STEMI
- Conditions
- Myocardial InfarctionCardiovascular Disease
- Registration Number
- NCT01459627
- Lead Sponsor
- Maasstad Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1100
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Net MACCE 18 months 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
Name Time Method All cause mortality, MI, Stroke, ST and bleeding 30 days Primary outcome of registry: All cause mortality, MI,Stroke, ST and Bleeding (following BARC) at 30 days.
All cause mortality, MACCE, TIMI 18 months DAPT-STEMI: All cause mortality, any MI, stroke, stent thrombosis (ST) and major bleeding (TIMI) at 18 months after randomization
Cardiac Mortality 30 days Registry: Cardiac Mortality at 30 days
all cause mortality 9 months DAPT-STEMI: All cause mortality at 9 months after randomization.
Target vessel MI 30 days Registry: Target vessel MI at 30 days.
Bleeding 18 months DAPT-STEMI: Bleeding at 18 months after randomization.
Target vessel failure 18 months DAPT STEMI: Target vessel failure (TVF) at 18 months after randomization.
Bleeding (BARC) 30 days Registry: Bleeding (BARC) at 30 days
ST definite/probable 18 months DAPT-STEMI: ST definite/probable academic research consortium (ARC) definition at 18 months post randomization.
MI 18 months DAPT-STEMI: Any MI at 18 months after randomization.
Target lesion failure 18 months DAPT-STEMI: Target lesion failure (TLF), at 18 months after randomization.
Stroke 2 days Registry: Stroke at 2 days
Bleeding BARC 2 days Registry: Bleeding (BARC) at 2 days
Cardiac mortality 2 days Registry: Cardiac Mortality at 2 days
Target vessel revascularization 18 months DAPT-STEMI: Target vessel revascularization (TVR) at 18 months after randomization.
Target lesion revascularization 18 months DAPT-STEMI: Target lesion revascularization (TLR) at 18 months after randomization.
All cause mortality 30 days Registry: All cause mortality at 30 days
ST following ARC 30 days Registry: ST following ARC definition at 30 days
stroke 9 months DAPT-STEMI: Stroke at 9 months after randomization.
net MACCE 6 months 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 MI 30 days Registry: All MI at 30 days.
Trial Locations
- Locations (15)
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
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