We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Treatment 90 days DAPT Drug: Treatment 360 days DAPT Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Short-term DUal Anti Platelet Therapy in Patients With Acute Coronary Syndrome Treated With the COMBO Dual-therapy stEnt
Actual Study Start Date : June 10, 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: DAPT 360 days
Treatment 360 days DAPT
 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
Active Comparator: DAPT 90 days
Treatment 90 days DAPT
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Bleeding (BARC II, III, V) at 360 days [ Time Frame: 360 days ]
  2. All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 360 and 720 days [ Time Frame: 720 days ]
  3. All cause mortality, MI, ST, stroke and TVR at 360 and 720 days [ Time Frame: 360 and 720 days ]
  4. Mortality at 360 and 720 days [ Time Frame: 360 and 720 days ]
  5. Cardiac Mortality at 360 and 720 days [ Time Frame: 360 and 720 days ]
  6. Any MI at 360 and 720 days [ Time Frame: 360 and 720 days ]
  7. ST at 360 and 720 days [ Time Frame: 360 and 720 days ]
  8. Repeat revascularization at 360 and 720 days [ Time Frame: 360 and 720 days ]
  9. 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 ]
  10. Prespecified landmark analysis of Primary Endpoint (without TVR) from 90 days to 360 days [ Time Frame: from 90 days to 360 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118870


Sponsors and Collaborators
Diagram B.V.
Investigators
Layout table for investigator information
Principal Investigator: H. Suryapranata, Prof. dr. Radboud University Medical Center
Principal Investigator: G. de Luca, Prof. dr. Eastern Piedmont University, Novara, Italy
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Diagram B.V.
ClinicalTrials.gov Identifier: NCT02118870    
Other Study ID Numbers: 9207
2013-005571-40 ( EudraCT Number )
14.0102 ( Other Identifier: Ethical Committee )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Keywords provided by Diagram B.V.:
ACS patients
Older than 18 years
PCI
Combo stent
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Clopidogrel
Ticagrelor
Prasugrel Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists