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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Diagram B.V.
Sponsor:
Information provided by (Responsible Party):
Diagram B.V.
ClinicalTrials.gov Identifier:
NCT02118870
First received: April 8, 2014
Last updated: May 19, 2014
Last verified: April 2014
  Purpose

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 (3 months) as compared to standard 12-month 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 (3 months) or to standard (12 months) 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 3, and 12 months, whereas a telephone contact will be performed at 6 and 24 months.

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 Intervention Phase
Acute Coronary Syndrome
Drug: Treatment 3 months DAPT
Drug: Treatment 12 months DAPT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Diagram B.V.:

Primary Outcome Measures:
  • Composite of all cause mortality, Myocardial Infarction (MI), ST, stroke, bleeding at 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: April 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DAPT 12 months
Treatment 12 months DAPT
Drug: Treatment 12 months DAPT
Long term (12 months) DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 12 months, 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 (12 months)DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up
  • to 12 months, after which patients will continue on monotherapy with ASA
  • only, unless contraindications for ASA emerge
Active Comparator: DAPT 3 months
Treatment 3 months DAPT
Drug: Treatment 3 months DAPT
Short term DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 3 months, 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 3 months, after which patients will continue.

Detailed Description:

Study sites:

Up to 30 investigational sites in Europe and Asia

Patients follow-up:

Follow-up (clinic) visits are scheduled at 3 and 12 months, whereas a telephone contact will be performed at 6 and 24 months. Patients randomized to short-term DAPT will continue on monotherapy with ASA after 3 months 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 12 months, 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 3 months, after which patients will continue.

Timelines:

Initial Enrollment: March 2014, Last Enrollment: March 2015, One year Follow-up: March 2016, Two year Follow-up: March 2017

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02118870

Contacts
Contact: S. Postma 31(0)384262999 reduce.study@diagram-zwolle.nl
Contact: J Klijn 31(0)384262999 j.klijn@diagram-zwolle.nl

Locations
Netherlands
Isala Recruiting
Zwolle, Overijssel, Netherlands, 8025 AB
Sponsors and Collaborators
Diagram B.V.
Investigators
Principal Investigator: H. Suryapranata, Prof. dr.
Principal Investigator: G. de Luca, MD. PhD.
  More Information

No publications provided

Responsible Party: Diagram B.V.
ClinicalTrials.gov Identifier: NCT02118870     History of Changes
Other Study ID Numbers: 9207, 2013-005571-40, 14.0102
Study First Received: April 8, 2014
Last Updated: May 19, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Diagram B.V.:
ACS patients
Older than 18 years
PCI
Combo stent

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Prasugrel
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014