Myocardial InfarctionPhase 4DAPT-STEMINCT01459627
Randomized, Open Label Trial of 6 Months Versus 12 Months DAPT After Drug-Eluting Stent in STEMI
A Phase 4 study testing 6 months DAPT and 12 months DAPT in people with Myocardial Infarction and Cardiovascular Disease, run by Maasstad Hospital at 16 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction, Cardiovascular Disease
- What is being tested?
- 6 months DAPT and 12 months DAPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Dec 2011to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI patients between 18-85 years who underwent primary PCI with DES implantation.
Who cannot join
- 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.
Show all 18Show fewer
- 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)
- 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
- Intolerance to Prasugrel, Ticagrelor, Bivalirudin.
- Known bleeding diathesis or known coagulopathy
- Report Resolute Integrity Exclusion criteria
- See exclusion criteria enrollment DAPT-STEMI protocol
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Netherlands8 sites
VU medisch Centrum
Amsterdam, 1081 HV
Amphia ziekenhuis
Breda, 4818CK
Medisch Spectrum Twente
Enschede
Atrium MC Parkstad
Heerlen
Maasstadhospital
Rotterdam, 3079DZ
Erasmus MC
Rotterdam
Haga Hospital
The Hague, 2512VA
Isala Clinics
Zwolle
Poland6 sites
Amerykańskie Kliniki Serca
Bielsko-Biala, 43316
Małopolskie Centrum Sercowo-Naczyniowe PAKS
Chrzanów, 32500
Polsko-Amerykańskie Kliniki Serca
Dąbrowa Górnicza, 41300
Polsko_Amerykanskei Kliniki Serca
Kędzierzyn-Koźle
University Hospital in Krakow
Krakow
Polsko_Amerykanskei Kliniki Serca
Nysa
About this study
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
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.
Read the 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.
- Conditions
- Myocardial Infarction, Cardiovascular Disease
- Being tested
- 6 months DAPT, 12 months DAPT
- Keywords
- DAPT- Dual Antiplatelet Therapy, STEMI
- Medical subject headings
- Myocardial Infarction, Cardiovascular Diseases, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 months DAPTOther
Also called ticagrelor, prasugrel, ASA
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 DAPTOther
Also called ticagrelor, prasugrel, ASA
Dual antiplatelet therapy will be continued till 12 months after enrollment in the study
| Study group | Role | What they receive |
|---|---|---|
| 6 months DAPT | Active comparator | Dual antiplatelet therapy consisting of aspirin (ASA) and prasugrel or ticagrelor will be discontinued after randomisation. Receives: Other: 6 months DAPT |
| 12 months DAPT | Active comparator | Dual antiplatelet therapy consisting of aspirin (ASA) and prasugrel or ticagrelor will be continued till 12 months after enrollment in the study Receives: Other: 12 months DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (41)
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.
Measured: 2 days
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
Measured: 9 months
ST definite/probable
DAPT-STEMI: ST definite/probable academic research consortium (ARC) definition at 9 months post randomization.
Measured: 9 months
all cause mortality
DAPT-STEMI: All cause mortality at 9 months after randomization.
Measured: 9 months
Cardiac mortality
DAPT-STEMI: Cardiac mortality at 9 months after randomization.
Measured: 9 months
MI
DAPT-STEMI: Any MI at 9 months after randomization.
Measured: 9 months
Target vessel MI
DAPT-STEMI: Target vessel MI at 9 months after randomization.
Measured: 9 months
Bleeding
DAPT-STEMI: Bleeding at 9 months after randomization.
Measured: 9 months
stroke
DAPT-STEMI: Stroke at 9 months after randomization.
Measured: 9 months
Target vessel revascularization
DAPT-STEMI: Target vessel revascularization (TVR) at 9 months after randomization.
Measured: 9 months
Target lesion revascularization
DAPT-STEMI: Target lesion revascularization (TLR) at 9 months after randomization.
Measured: 9 months
Target vessel failure
DAPT STEMI: Target vessel failure (TVF) at 9 months after randomization.
Measured: 9 months
Target lesion failure
DAPT-STEMI: Target lesion failure (TLF), at 9 months after randomization.
Measured: 9 months
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.
Measured: 30days
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.
Measured: 30 days
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.
Measured: 6 months
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
Measured: 18 months
ST definite/probable
DAPT-STEMI: ST definite/probable academic research consortium (ARC) definition at 18 months post randomization.
Measured: 18 months
All cause mortality
DAPT-STEMI: All cause mortality at 18 months after randomization.
Measured: 18 months
Cardiac mortality
DAPT-STEMI: Cardiac mortality at 18 months after randomization.
Measured: 18 months
MI
DAPT-STEMI: Any MI at 18 months after randomization.
Measured: 18 months
Target vessel MI
DAPT-STEMI: Target vessel MI at 18 months after randomization.
Measured: 18 months
Bleeding
DAPT-STEMI: Bleeding at 18 months after randomization.
Measured: 18 months
Stroke
DAPT-STEMI: Stroke at 18 months after randomization.
Measured: 18 months
Target vessel revascularization
DAPT-STEMI: Target vessel revascularization (TVR) at 18 months after randomization.
Measured: 18 months
Target lesion revascularization
DAPT-STEMI: Target lesion revascularization (TLR) at 18 months after randomization.
Measured: 18 months
Target vessel failure
DAPT STEMI: Target vessel failure (TVF) at 18 months after randomization.
Measured: 18 months
Target lesion failure
DAPT-STEMI: Target lesion failure (TLF), at 18 months after randomization.
Measured: 18 months
ST following ARC
Registry: ST following ARC definition at 2 days
Measured: 2 days
ST following ARC
Registry: ST following ARC definition at 30 days
Measured: 30 days
All cause mortality
Registry: All cause mortality at 2 days
Measured: 2 days
All cause mortality
Registry: All cause mortality at 30 days
Measured: 30 days
Cardiac mortality
Registry: Cardiac Mortality at 2 days
Measured: 2 days
Cardiac Mortality
Registry: Cardiac Mortality at 30 days
Measured: 30 days
All MI
Registry: All MI at 2 days.
Measured: 2 days
All MI
Registry: All MI at 30 days.
Measured: 30 days
Target vessel MI
Registry: Target vessel MI at 2 days.
Measured: 2 days
Target vessel MI
Registry: Target vessel MI at 30 days.
Measured: 30 days
Bleeding BARC
Registry: Bleeding (BARC) at 2 days
Measured: 2 days
Bleeding (BARC)
Registry: Bleeding (BARC) at 30 days
Measured: 30 days
Stroke
Registry: Stroke at 2 days
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Elvin Kedhi, MD PHD, Principal investigator, IsalaMartin van der Ent, MD PhD, Principal investigator, Maasstadhospital / MCR B.V.Clemens von Birgelen, MD PhD, Study chair, Medisch Spectrum TwenteFelix Zijlstra, MD PhD, Study chair, Erasmus Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459627
- Sponsor's protocol ID
- DAPT-STEMI
- Acronym
- DAPT-STEMI
- Status last verified
- Sep 2017
- First submitted
- 18 Oct 2011
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kedhi E, Delewi R, Fabris E, De Luca G, Hermanides RS, van den Ent M, Buszman P, Zijlstra F, Song YB, Gwon HC, Hahn JY. Duration of dual antiplatelet therapy after myocardial infarction: Insights from a pooled database of the SMART-DATE and DAPT-STEMI trials. Atherosclerosis. 2020 Dec;315:55-61. doi: 10.1016/j.atherosclerosis.2020.11.003. Epub 2020 Nov 9.
PubMed 33227548Postma W, Fabris E, Van der Ent M, Hermanides R, Buszman P, Von Birgelen C C, Cook S, Wedel H, De Luca G, Delewi R, Zijlstra F, Kedhi E. Resolute zotarolimus-eluting stent in ST-elevation myocardial infarction (resolute-STEMI): A prespecified prospective register from the DAPT-STEMI trial. Catheter Cardiovasc Interv. 2020 Mar 1;95(4):706-710. doi: 10.1002/ccd.28376. Epub 2019 Jul 3.
PubMed 31268629Kedhi E, Fabris E, van der Ent M, Buszman P, von Birgelen C, Roolvink V, Zurakowski A, Schotborgh CE, Hoorntje JCA, Eek CH, Cook S, Togni M, Meuwissen M, van Royen N, van Vliet R, Wedel H, Delewi R, Zijlstra F. Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial. BMJ. 2018 Oct 2;363:k3793. doi: 10.1136/bmj.k3793.
PubMed 30279197
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01459627
- Acronym / sponsor ID
- DAPT-STEMI / DAPT-STEMI
- Conditions
- Myocardial Infarction, Cardiovascular Disease
- Keywords
- DAPT- Dual Antiplatelet Therapy, STEMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Dec 2011
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 months DAPT | Active comparator | Other: 6 months DAPTDual antiplatelet therapy consisting of aspirin (ASA) and prasugrel or ticagrelor will be discontinued after randomisation. |
| 12 months DAPT | Active comparator | Other: 12 months DAPTDual antiplatelet therapy consisting of aspirin (ASA) and prasugrel or ticagrelor will be continued till 12 months after enrollment in the study |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- STEMI patients between 18-85 years who underwent primary PCI with DES implantation.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 months DAPTAlso: ticagrelor, prasugrel, ASADual 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 | 6 months DAPT |
| 12 months DAPTAlso: ticagrelor, prasugrel, ASADual antiplatelet therapy will be continued till 12 months after enrollment in the study | Other | 12 months DAPT |
Primary outcome
Net MACCE
Time frame: 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
41 secondary outcomes
All cause mortality, MI, Stroke, ST and bleeding
Time frame: 2 days
All cause mortality, MACCE, TIMI
Time frame: 9 months
ST definite/probable
Time frame: 9 months
all cause mortality
Time frame: 9 months
Cardiac mortality
Time frame: 9 months
MI
Time frame: 9 months
Target vessel MI
Time frame: 9 months
Bleeding
Time frame: 9 months
stroke
Time frame: 9 months
Target vessel revascularization
Time frame: 9 months
Target lesion revascularization
Time frame: 9 months
Target vessel failure
Time frame: 9 months
Target lesion failure
Time frame: 9 months
net MACCE
Time frame: 30days
All cause mortality, MI, Stroke, ST and bleeding
Time frame: 30 days
net MACCE
Time frame: 6 months
All cause mortality, MACCE, TIMI
Time frame: 18 months
ST definite/probable
Time frame: 18 months
All cause mortality
Time frame: 18 months
Cardiac mortality
Time frame: 18 months
MI
Time frame: 18 months
Target vessel MI
Time frame: 18 months
Bleeding
Time frame: 18 months
Stroke
Time frame: 18 months
Target vessel revascularization
Time frame: 18 months
Target lesion revascularization
Time frame: 18 months
Target vessel failure
Time frame: 18 months
Target lesion failure
Time frame: 18 months
ST following ARC
Time frame: 2 days
ST following ARC
Time frame: 30 days
All cause mortality
Time frame: 2 days
All cause mortality
Time frame: 30 days
Cardiac mortality
Time frame: 2 days
Cardiac Mortality
Time frame: 30 days
All MI
Time frame: 2 days
All MI
Time frame: 30 days
Target vessel MI
Time frame: 2 days
Target vessel MI
Time frame: 30 days
Bleeding BARC
Time frame: 2 days
Bleeding (BARC)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Derived from this study: PubMed 33227548Kedhi E, Delewi R, Fabris E, De Luca G, Hermanides RS, van den Ent M, Buszman P, Zijlstra F, Song YB, Gwon HC, Hahn JY. Duration of dual antiplatelet therapy after myocardial infarction: Insights from a pooled database of the SMART-DATE and DAPT-STEMI trials. Atherosclerosis. 2020 Dec;315:55-61. doi: 10.1016/j.atherosclerosis.2020.11.003. Epub 2020 Nov 9.
- Derived from this study: PubMed 31268629Postma W, Fabris E, Van der Ent M, Hermanides R, Buszman P, Von Birgelen C C, Cook S, Wedel H, De Luca G, Delewi R, Zijlstra F, Kedhi E. Resolute zotarolimus-eluting stent in ST-elevation myocardial infarction (resolute-STEMI): A prespecified prospective register from the DAPT-STEMI trial. Catheter Cardiovasc Interv. 2020 Mar 1;95(4):706-710. doi: 10.1002/ccd.28376. Epub 2019 Jul 3.
- Derived from this study: PubMed 30279197Kedhi E, Fabris E, van der Ent M, Buszman P, von Birgelen C, Roolvink V, Zurakowski A, Schotborgh CE, Hoorntje JCA, Eek CH, Cook S, Togni M, Meuwissen M, van Royen N, van Vliet R, Wedel H, Delewi R, Zijlstra F. Six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction (DAPT-STEMI): randomised, multicentre, non-inferiority trial. BMJ. 2018 Oct 2;363:k3793. doi: 10.1136/bmj.k3793.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elvin Kedhi, MD PHD principal investigator
Isala
Martin van der Ent, MD PhD principal investigator
Maasstadhospital / MCR B.V.
Clemens von Birgelen, MD PhD study chair
Medisch Spectrum Twente
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 6 months DAPT and 12 months DAPT in people with Myocardial Infarction and Cardiovascular Disease, run by Maasstad Hospital at 16 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Netherlands, Poland, Norway, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net MACCE (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01459627, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.