Ignite Creation Date:
2024-05-06 @ 2:43 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02118870
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2014-04-08
Brief Title:
Short-term Dual Anti Platelet Therapy in Patients With ACS Treated With the COMBO Dual-therapy Stent
Sponsor:
Diagram BV
Organization:
Diagram BV
Study Overview
Official Title:
Randomized Evaluation of Short-term DUal Anti Platelet Therapy in Patients With Acute Coronary Syndrome Treated With the COMBO Dual-therapy stEnt
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REDUCE
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 11 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
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 11 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 mgday or Ticagrelor 180 mgday are strongly recommended as compared to Clopidogrel 75 mgday 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
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 mgday or Ticagrelor 180 mgday are strongly recommended as compared to Clopidogrel 75 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 140102 | OTHER | Ethical Committee | None |
| 2013-005571-40 | EUDRACT_NUMBER | None | None |