Status:
COMPLETED
Randomized, Open Label Trial of 6 Months Versus 12 Months DAPT After Drug-Eluting Stent in STEMI
Lead Sponsor:
Maasstad Hospital
Collaborating Sponsors:
Medtronic
Conditions:
Myocardial Infarction
Cardiovascular Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 Infarctio...
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 ra...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2017
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT01459627
Start Date
December 1 2011
End Date
August 1 2017
Last Update
September 7 2017
Active Locations (16)
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1
VU medisch Centrum
Amsterdam, Netherlands, 1081 HV
2
Amphia ziekenhuis
Breda, Netherlands, 4818CK
3
Medisch Spectrum Twente
Enschede, Netherlands
4
Atrium MC Parkstad
Heerlen, Netherlands