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Randomized Evaluation of short-term Dual anti platelet therapy in patients with acute coronary syndrome treated with the COMBO dual-therapy stEnt.


- candidate number16398
- NTR NumberNTR4386
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2014
- Secondary IDsNL47464.075.13 
- Public TitleRandomized Evaluation of short-term Dual anti platelet therapy in patients with acute coronary syndrome treated with the COMBO dual-therapy stEnt.
- Scientific TitleRandomized evaluation of short-term dual anti platelet therapy in patients with acute coronary syndrome treated with the COMBO dual-therapy stent.
- ACRONYMREDUCE trial
- hypothesisAim of the current study is to demonstrate a non-inferiority of a strategy of short-term DAPT (90 days) as compared to standard 360 days DAPT in ACS patients treated with Combo stent.
- Healt Condition(s) or Problem(s) studiedAcute coronary syndrome (ACS)
- Inclusion criteria- The patient must be ≥ 18 years of age - The patient has been diagnosed with STEMI, NSTEMI or UA - The patient is willing to comply with specified follow-up evaluations - The patient has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC) - Successful COMBO stent implantation (TIMI 3 flow with residual stenosis < 20% based visual estimation), with no clinical adverse event during hospitalization (Death, stent thrombosis (ST), stroke, target vessel revascularisation (TVR), bleeding (BARC II, III, V))
- Exclusion criteria- Patients presenting with cardiogenic shock - Patients with recent major bleeding complications or contraindication to DAPT, such as: a) Hypersensitivity to Aspirin, Clopidogrel, Prasugrel or Ticagrelor b) Need for oral anticoagulation c) History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia) or refusal of blood transfusions d) History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke e) Stroke or transient ischemic attack within the past 6 months or any permanent residual neurologic defect f) Gastrointestinal or genitourinary bleeding within the last 2 months or major surgery within 6 weeks g) Recent history or known current platelet count <100 000 cells/mm3 or hemoglobin <10 g/dL h) An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment - Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.) - Planned intervention of another lesion (target vessel or non-target vessel) after index hospital discharge - Any revascularization performed within index hospitalization with other stents than COMBO - Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits - Patients requiring permanent DAPT due to comorbidities - Patient has received any organ transplant or is on a waiting list for any organ transplant - Life expectancy of less than 2 years - Pregnancy or intention to become pregnant during the course of the trial - Any significant medical or mental condition, which in the Investigators opinion may interfere with the patients optimal participation in the study - Currently participating in another investigational drug or device study - Patients who have been treated with another DES within 9 months prior to the index procedure
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2014
- planned closingdate1-mei-2018
- Target number of participants1500
- InterventionsIntervention: 90 days DAPT Control: 360 days DAPT
- Primary outcomeComposite of all cause mortality, Myocardial Infarction (MI), stent thrombosis(ST), stroke, target vessel revascularization (TVR) or bleeding (BARC II, III,V) at 360 days.
- Secondary outcomeBleeding (BARC II, III, V) at 360 days,All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 360 and 720 days,All cause mortality, MI, ST, stroke and TVR at 360 and 720 days. Mortality at 360 and 720 days,Cardiac Mortality at 360 and 720 days,Any MI at 360 and 720 days,ST at 360 and 720 days,Repeat revascularization at 360 and 720 days,Time to event as defined by the occurrence of one of the following: all cause mortality, MI, ST, stroke, TVR or bleeding (BARC II, III, V) within 360 and 720 days,Prespecified landmark analysis of Primary Endpoint (without TVR) from 90 to 360 days.
- Timepoints90 days, 180 days, 360 days, 720 days
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Sonja Postma
- CONTACT for SCIENTIFIC QUERIES E. Kedhi
- Sponsor/Initiator Diagram B.V.
- Funding
(Source(s) of Monetary or Material Support)
Isala Clinics, Department of Cardiology, OrbusNeich
- PublicationsN/A
- Brief summaryProspective, multicenter, randomized investigator-initiated study designed to enroll 1500 patients with ACS receiving a COMBO stent. Patients will be randomized before discharge into a 1:1 fashion to either 90 or 360 days DAPT. Follow-up is scheduled at 90 days, 90 days, 360 days, and 720 days.
- Main changes (audit trail)7-okt-2017 -IK:
Withdrawal of Isala Hospital as sponsor. Replaced by Diagram BV
- RECORD11-feb-2014 - 7-okt-2017


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