Acute Coronary SyndromePhase 4REDUCENCT02118870
Short-term Dual Anti Platelet Therapy in Patients With ACS Treated With the COMBO Dual-therapy Stent
A Phase 4 study testing Treatment 90 days DAPT and Treatment 360 days DAPT in people with Acute Coronary Syndrome, run by Diagram B.V..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Treatment 90 days DAPT and Treatment 360 days DAPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2014to Sep 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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
Show all 21Show fewer
- 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
About this study
Official title: Randomized Evaluation of Short-term DUal Anti Platelet Therapy in Patients With Acute Coronary Syndrome Treated With the COMBO Dual-therapy stEnt
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.
Read more
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.
Read the 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
- Conditions
- Acute Coronary Syndrome
- Being tested
- Treatment 90 days DAPT, Treatment 360 days DAPT
- Keywords
- ACS patients, Older than 18 years, PCI, Combo stent
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment 90 days DAPTDrug
Also called 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
Short term DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 90 days, after which patients will continue.
Treatment 360 days DAPTDrug
Also called 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
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 group | Role | What they receive |
|---|---|---|
| DAPT 360 days | Active comparator | Treatment 360 days DAPT Receives: Drug: Treatment 360 days DAPT |
| DAPT 90 days | Active comparator | Treatment 90 days DAPT Receives: Drug: Treatment 90 days DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all cause mortality, Myocardial Infarction (MI), ST, stroke, taret vessel revascularization (TVR) and bleeding (BARC II, III and V) at 360 days
Measured: At 360 days
Secondary outcomes (10)
Bleeding (BARC II, III, V) at 360 days
Measured: 360 days
All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 360 and 720 days
Measured: 720 days
All cause mortality, MI, ST, stroke and TVR at 360 and 720 days
Measured: 360 and 720 days
Mortality at 360 and 720 days
Measured: 360 and 720 days
Cardiac Mortality at 360 and 720 days
Measured: 360 and 720 days
Any MI at 360 and 720 days
Measured: 360 and 720 days
ST at 360 and 720 days
Measured: 360 and 720 days
Repeat revascularization at 360 and 720 days
Measured: 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
Measured: 360 and 720 days
Prespecified landmark analysis of Primary Endpoint (without TVR) from 90 days to 360 days
Measured: from 90 days to 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study start10 Jun 2014
- Primary completionSep 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diagram B.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H. Suryapranata, Prof. dr., Principal investigator, Radboud University Medical CenterG. de Luca, Prof. dr., Principal investigator, Eastern Piedmont University, Novara, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118870
- Sponsor's protocol ID
- 9207
- Other IDs
- 2013-005571-40, 14.0102
- Acronym
- REDUCE
- Status last verified
- Feb 2019
- First submitted
- 8 Apr 2014
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Short-term DUal Anti Platelet Therapy in Patients With Acute Coronary Syndrome Treated With the COMBO Dual-therapy stEnt
- ClinicalTrials.gov ID
- NCT02118870
- Acronym / sponsor ID
- REDUCE / 9207
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS patients, Older than 18 years, PCI, Combo stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Diagram B.V.University, hospital or other
- Study start
- 10 Jun 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAPT 360 days | Active comparator | Drug: Treatment 360 days DAPTTreatment 360 days DAPT |
| DAPT 90 days | Active comparator | Drug: Treatment 90 days DAPTTreatment 90 days DAPT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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))
Key exclusion criteria (21 listed)
- Patients presenting with cardiogenic shock
- Patients with recent major bleeding complications or contraindication to DAPT, such as:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment 90 days DAPTAlso: 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 upShort term DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 90 days, after which patients will continue. | Drug | DAPT 90 days |
| Treatment 360 days DAPTAlso: 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 upLong 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 | Drug | DAPT 360 days |
Primary outcome
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
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Suryapranata, Prof. dr. principal investigator
Radboud University Medical Center
G. de Luca, Prof. dr. principal investigator
Eastern Piedmont University, Novara, Italy
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment 90 days DAPT and Treatment 360 days DAPT in people with Acute Coronary Syndrome, run by Diagram B.V..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.