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

Myocardial Infarction Clinical Trial

— DAPT-STEMI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459627
• Other study ID #: DAPT-STEMI
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2011
• Last updated: September 6, 2017
• Start date: December 2011
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: Maasstad Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Netherlands	VU medisch Centrum	Amsterdam
Netherlands	Amphia ziekenhuis	Breda
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Atrium MC Parkstad	Heerlen
Netherlands	Erasmus MC	Rotterdam
Netherlands	Maasstadhospital	Rotterdam
Netherlands	Haga Hospital	The Hague
Netherlands	Isala Clinics	Zwolle
Norway	Oslo University Hospital	Oslo
Poland	Amerykanskie Kliniki Serca	Bielsko-Biala
Poland	Malopolskie Centrum Sercowo-Naczyniowe PAKS	Chrzanów
Poland	Polsko-Amerykanskie Kliniki Serca	Dabrowa Górnicza
Poland	Polsko_Amerykanskei Kliniki Serca	Kedzierzyn Kozle
Poland	University Hospital in Krakow	Krakow
Poland	Polsko_Amerykanskei Kliniki Serca	Nysa
Switzerland	Hôpital Cantonal Fribourg	Fribourg

Sponsors (2)

Lead Sponsor	Collaborator
Maasstad Hospital	Medtronic

Countries where clinical trial is conducted

Netherlands,  Norway,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All cause mortality, MI, Stroke, ST and bleeding	Primary outcome of Registry: All cause mortality, MI, Stroke, ST and Bleeding(following BARC)at 2 days.	2 days
Secondary	All cause mortality, MACCE, TIMI	DAPT-STEMI: All cause mortality, any MI, stroke, stent thrombosis (ST) and major bleeding (TIMI) at 9 months after randomization	9 months
Secondary	ST definite/probable	DAPT-STEMI: ST definite/probable academic research consortium (ARC) definition at 9 months post randomization.	9 months
Secondary	all cause mortality	DAPT-STEMI: All cause mortality at 9 months after randomization.	9 months
Secondary	Cardiac mortality	DAPT-STEMI: Cardiac mortality at 9 months after randomization.	9 months
Secondary	MI	DAPT-STEMI: Any MI at 9 months after randomization.	9 months
Secondary	Target vessel MI	DAPT-STEMI: Target vessel MI at 9 months after randomization.	9 months
Secondary	Bleeding	DAPT-STEMI: Bleeding at 9 months after randomization.	9 months
Secondary	stroke	DAPT-STEMI: Stroke at 9 months after randomization.	9 months
Secondary	Target vessel revascularization	DAPT-STEMI: Target vessel revascularization (TVR) at 9 months after randomization.	9 months
Secondary	Target lesion revascularization	DAPT-STEMI: Target lesion revascularization (TLR) at 9 months after randomization.	9 months
Secondary	Target vessel failure	DAPT STEMI: Target vessel failure (TVF) at 9 months after randomization.	9 months
Secondary	Target lesion failure	DAPT-STEMI: Target lesion failure (TLF), at 9 months after randomization.	9 months
Secondary	net MACCE	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.	30days
Secondary	All cause mortality, MI, Stroke, ST and bleeding	Primary outcome of registry: All cause mortality, MI,Stroke, ST and Bleeding (following BARC) at 30 days.	30 days
Secondary	net MACCE	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.	6 months
Secondary	All cause mortality, MACCE, TIMI	DAPT-STEMI: All cause mortality, any MI, stroke, stent thrombosis (ST) and major bleeding (TIMI) at 18 months after randomization	18 months
Secondary	ST definite/probable	DAPT-STEMI: ST definite/probable academic research consortium (ARC) definition at 18 months post randomization.	18 months
Secondary	All cause mortality	DAPT-STEMI: All cause mortality at 18 months after randomization.	18 months
Secondary	Cardiac mortality	DAPT-STEMI: Cardiac mortality at 18 months after randomization.	18 months
Secondary	MI	DAPT-STEMI: Any MI at 18 months after randomization.	18 months
Secondary	Target vessel MI	DAPT-STEMI: Target vessel MI at 18 months after randomization.	18 months
Secondary	Bleeding	DAPT-STEMI: Bleeding at 18 months after randomization.	18 months
Secondary	Stroke	DAPT-STEMI: Stroke at 18 months after randomization.	18 months
Secondary	Target vessel revascularization	DAPT-STEMI: Target vessel revascularization (TVR) at 18 months after randomization.	18 months
Secondary	Target lesion revascularization	DAPT-STEMI: Target lesion revascularization (TLR) at 18 months after randomization.	18 months
Secondary	Target vessel failure	DAPT STEMI: Target vessel failure (TVF) at 18 months after randomization.	18 months
Secondary	Target lesion failure	DAPT-STEMI: Target lesion failure (TLF), at 18 months after randomization.	18 months
Secondary	ST following ARC	Registry: ST following ARC definition at 2 days	2 days
Secondary	ST following ARC	Registry: ST following ARC definition at 30 days	30 days
Secondary	All cause mortality	Registry: All cause mortality at 2 days	2 days
Secondary	All cause mortality	Registry: All cause mortality at 30 days	30 days
Secondary	Cardiac mortality	Registry: Cardiac Mortality at 2 days	2 days
Secondary	Cardiac Mortality	Registry: Cardiac Mortality at 30 days	30 days
Secondary	All MI	Registry: All MI at 2 days.	2 days
Secondary	All MI	Registry: All MI at 30 days.	30 days
Secondary	Target vessel MI	Registry: Target vessel MI at 2 days.	2 days
Secondary	Target vessel MI	Registry: Target vessel MI at 30 days.	30 days
Secondary	Bleeding BARC	Registry: Bleeding (BARC) at 2 days	2 days
Secondary	Bleeding (BARC)	Registry: Bleeding (BARC) at 30 days	30 days
Secondary	Stroke	Registry: Stroke at 2 days	2 days