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Short-term Dual Anti Platelet Therapy in Patients With ACS Treated With the COMBO Dual-therapy Stent (REDUCE)

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ClinicalTrials.gov Identifier: NCT02118870
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Diagram B.V.

Tracking Information
First Submitted Date  ICMJE April 8, 2014
First Posted Date  ICMJE April 21, 2014
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE June 10, 2014
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
Composite of all cause mortality, Myocardial Infarction (MI), ST, stroke, taret vessel revascularization (TVR) and bleeding (BARC II, III and V) at 360 days [ Time Frame: At 360 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2014)
Composite of all cause mortality, Myocardial Infarction (MI), ST, stroke, bleeding at 12 months [ Time Frame: At 12 months ]
Change History Complete list of historical versions of study NCT02118870 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • Bleeding (BARC II, III, V) at 360 days [ Time Frame: 360 days ]
  • All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 360 and 720 days [ Time Frame: 720 days ]
  • All cause mortality, MI, ST, stroke and TVR at 360 and 720 days [ Time Frame: 360 and 720 days ]
  • Mortality at 360 and 720 days [ Time Frame: 360 and 720 days ]
  • Cardiac Mortality at 360 and 720 days [ Time Frame: 360 and 720 days ]
  • Any MI at 360 and 720 days [ Time Frame: 360 and 720 days ]
  • ST at 360 and 720 days [ Time Frame: 360 and 720 days ]
  • Repeat revascularization at 360 and 720 days [ Time Frame: 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 [ Time Frame: 360 and 720 days ]
  • Prespecified landmark analysis of Primary Endpoint (without TVR) from 90 days to 360 days [ Time Frame: from 90 days to 360 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2014)
Prespecified landmark analysis of Primary Endpoint from 3 to 12 months,Bleeding at 12 months, All cause mortality, MI, ST, stroke, bleeding at 24 months, All cause mortality, MI, ST, stroke at 12 and 24 months [ Time Frame: 3,12,24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short-term Dual Anti Platelet Therapy in Patients With ACS Treated With the COMBO Dual-therapy Stent
Official Title  ICMJE Randomized Evaluation of Short-term DUal Anti Platelet Therapy in Patients With Acute Coronary Syndrome Treated With the COMBO Dual-therapy stEnt
Brief Summary

Background:

The optimal duration of dual antiplatelet therapy in ACS patients treated with DES is still under debate. This is especially true for STEMI patients in the era of new anticoagulants and antiplatelet agents. Yet, the potential benefits of longterm dual antiplatelet therapy in avoiding thrombotic complications may be clearly counterbalanced by a higher risk of major bleeding complications. In particular, the COMBO dual therapy stent, being associated with early re-endothelization, may allow for a reduction of the duration of DAPT (dual anti plateled therapy) without increasing the thrombotic risk, while reducing the risk of severe bleeding complications.

Study Objective:

Aim 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.

Study Design:

This study is a prospective, multicenter, randomized, investigator-initiated study designed to enroll 1500 patients with ACS receiving a COMBO dual-therapy stent who will be randomized 1:1 to either short term (90 days) or to standard (360 days) DAPT. Patients will be randomized within hospitalization (before discharge in case additional revascularization is deemed necessary and performed during hospitalization). Clinical visit is scheduled at 90, and 360 days, whereas a telephone contact will be performed at 180 and 720 days.

Patient Population:

The study population will consist of up to 1500 ACS patients (male and female) older than 18 years amenable to percutaneous treatment and treated with a COMBO stent. Subjects must meet all of the eligibility criteria and provide written informed consent.

Detailed Description

Study sites:

Up to 40 investigational sites in Europe and Asia

Patients follow-up:

Follow-up (clinic) visits are scheduled at 90 and 360 days, whereas a telephone contact will be performed at 180 and 720 days. Patients randomized to short-term DAPT will continue on monotherapy with ASA after 90 days unless contraindicated.

Antiplatelet therapy:

Subjects will be treated with Aspirin and P2Y12 inhibitor. Prasugrel (10 mg/day) or Ticagrelor (180 mg/day) are strongly recommended as compared to Clopidogrel (75 mg/day)). Long term DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 360 days, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge Short term DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 90 days, after which patients will continue.

Timelines:

First Enrollment: June 2014 Last Enrollment: May 2016 One year Follow-up: May 2018 Two year Follow-up: May 2019

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: Treatment 90 days DAPT
    Short term DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 90 days, after which patients will continue.
    Other Names:
    • Subjects will be treated with Aspirin and P2Y12 inhibitor. Prasugrel (10
    • mg/day) or Ticagrelor (180 mg/day) are strongly recommended as compared
    • to Clopidogrel (75 mg/day)).
    • Short term DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up
    • to 90 days, after which patients will continue.
  • Drug: Treatment 360 days DAPT
    Long term (360 days) DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 360 days, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge
    Other Names:
    • Subjects will be treated with Aspirin and P2Y12 inhibitor. Prasugrel (10
    • mg/day) or Ticagrelor (180 mg/day) are strongly recommended as compared
    • to Clopidogrel (75 mg/day)).
    • Long term (360 days) DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up
    • to 360 days, after which patients will continue on monotherapy with ASA
    • only, unless contraindications for ASA emerge
Study Arms  ICMJE
  • Active Comparator: DAPT 360 days
    Treatment 360 days DAPT
    Intervention: Drug: Treatment 360 days DAPT
  • Active Comparator: DAPT 90 days
    Treatment 90 days DAPT
    Intervention: Drug: Treatment 90 days DAPT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2014)
1500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patient must be ≥18 years of age
  2. The patient has been diagnosed with STEMI, NSTEMI or UA
  3. The Patient is willing to comply with specified follow-up evaluations
  4. 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)
  5. Successful COMBO stent implantation (TIMI 3 flow with residual stenosis < 20% based visual estimation), with no clinical adverse event during hospitalization (Death, ST, stroke, TVR, bleeding (BARC II, III, V))

Exclusion Criteria:

  1. Patients presenting with cardiogenic shock
  2. Patients with recent major bleeding complications or contraindication to DAPT, such as:

    1. Hypersensitivity to Aspirin, Clopidogrel, Prasugrel or Ticagrelor
    2. Need for oral anticoagulation
    3. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia) or refusal of blood transfusions
    4. History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
    5. Stroke or transient ischemic attack within the past 6 months or any permanent residual neurologic defect
    6. Gastrointestinal or genitourinary bleeding within the last 2 months or major surgery within 6 weeks
    7. Recent history or known current platelet count <100 000 cells/mm3 or hemoglobin <10 g/dL
    8. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment
  3. Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.)
  4. Planned intervention of another lesion (target vessel or non-target vessel) after index hospital discharge
  5. Any revascularization performed within index hospitalization with other stents than COMBO
  6. Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
  7. Patients requiring permanent DAPT due to comorbidities
  8. Patient has received any organ transplant or is on a waiting list for any organ transplant
  9. Life expectancy of less than 2 years
  10. Pregnancy or intention to become pregnant during the course of the trial
  11. Any significant medical or mental condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study
  12. Currently participating in another investigational drug or device study
  13. Patients who have been treated with another DES within 9 months prior to the index procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT02118870
Other Study ID Numbers  ICMJE 9207
2013-005571-40 ( EudraCT Number )
14.0102 ( Other Identifier: Ethical Committee )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Diagram B.V.
Study Sponsor  ICMJE Diagram B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: H. Suryapranata, Prof. dr. Radboud University
Principal Investigator: G. de Luca, Prof. dr. Eastern Piedmont University, Novara, Italy
PRS Account Diagram B.V.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP