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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Treatment 90 days DAPT

Treatment 360 days DAPT

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring ACS patients, Older than 18 years, PCI, Combo stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, ST, stroke, 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:
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
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 Investigator's opinion may interfere with the patient's 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

DAPT 360 days

DAPT 90 days

Arm Description

Treatment 360 days DAPT

Treatment 90 days DAPT

Outcomes

Primary Outcome Measures

Composite of all cause mortality, Myocardial Infarction (MI), ST, stroke, taret vessel revascularization (TVR) and bleeding (BARC II, III and V) at 360 days

Secondary Outcome Measures

Bleeding (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 days to 360 days

Full Information

NCT ID

NCT02118870

First Posted

April 8, 2014

Last Updated

February 7, 2019

Sponsor

Diagram B.V.

1. Study Identification

Unique Protocol Identification Number

NCT02118870

Brief Title

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

Acronym

REDUCE

Official Title

Randomized Evaluation of Short-term DUal Anti Platelet Therapy in Patients With Acute Coronary Syndrome Treated With the COMBO Dual-therapy stEnt

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

June 10, 2014 (Actual)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Diagram B.V.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

ACS patients, Older than 18 years, PCI, Combo stent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DAPT 360 days

Arm Type

Active Comparator

Arm Description

Treatment 360 days DAPT

Arm Title

DAPT 90 days

Arm Type

Active Comparator

Arm Description

Treatment 90 days DAPT

Intervention Type

Drug

Intervention Name(s)

Treatment 90 days DAPT

Other Intervention Name(s)

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.

Intervention Description

Short term DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 90 days, after which patients will continue.

Intervention Type

Drug

Intervention Name(s)

Treatment 360 days DAPT

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Bleeding (BARC II, III, V) at 360 days

Time Frame

360 days

Title

All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 360 and 720 days

Time Frame

720 days

Title

All cause mortality, MI, ST, stroke and TVR at 360 and 720 days

Time Frame

360 and 720 days

Title

Mortality at 360 and 720 days

Time Frame

360 and 720 days

Title

Cardiac Mortality at 360 and 720 days

Time Frame

360 and 720 days

Title

Any MI at 360 and 720 days

Time Frame

360 and 720 days

Title

ST at 360 and 720 days

Time Frame

360 and 720 days

Title

Repeat revascularization at 360 and 720 days

Time Frame

360 and 720 days

Title

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

Title

Prespecified landmark analysis of Primary Endpoint (without TVR) from 90 days to 360 days

Time Frame

from 90 days to 360 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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, ST, stroke, 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: Hypersensitivity to Aspirin, Clopidogrel, Prasugrel or Ticagrelor Need for oral anticoagulation History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia) or refusal of blood transfusions History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke Stroke or transient ischemic attack within the past 6 months or any permanent residual neurologic defect Gastrointestinal or genitourinary bleeding within the last 2 months or major surgery within 6 weeks Recent history or known current platelet count <100 000 cells/mm3 or hemoglobin <10 g/dL 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 Investigator's opinion may interfere with the patient's 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

H. Suryapranata, Prof. dr.

Organizational Affiliation

Radboud University Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

G. de Luca, Prof. dr.

Organizational Affiliation

Eastern Piedmont University, Novara, Italy

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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