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

NCT02118870 | Completed Phase 4 DMC

• 3 other identifiers: 92072013-005571-4014.0102
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Coronary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (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

  At 360 days

Secondary Outcomes (10)

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

  360 days

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

  720 days

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

  360 and 720 days

• Mortality at 360 and 720 days

  360 and 720 days

• Cardiac Mortality at 360 and 720 days

  360 and 720 days

Study Arms (2)

DAPT 360 days

ACTIVE COMPARATOR

Treatment 360 days DAPT

Drug: Treatment 360 days DAPT

DAPT 90 days

ACTIVE COMPARATOR

Treatment 90 days DAPT

Drug: Treatment 90 days DAPT

Interventions

Treatment 90 days DAPT DRUG

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

Also known as: 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.

DAPT 90 days

Treatment 360 days DAPT DRUG

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

Also known as: 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

DAPT 360 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• Diagram B.V.: lead

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Therapeutics; 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine; Aspirin; Ticagrelor; Single Person

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• H. Suryapranata, Prof. dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• G. de Luca, Prof. dr.

  Eastern Piedmont University, Novara, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 21, 2014
• Study Start: June 10, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: February 8, 2019

Record last verified: 2019-02