Randomized Evaluation of short-term DUal anti platelet therapy in patients with acute coronary syndrome treated with the COMBO dual-therapy stEnt

Randomized Evaluation of short-term DUal anti platelet therapy in patients with acute coronary syndrome treated with the COMBO dual-therapy stEnt - REDUCE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41374

Enrollment

350

Registered

2014-01-14

Start date

2014-06-05

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute coronary syndrom obstruction blood vessel of the heart

Interventions

intervention: 3 months DAPT control: 12 months DAPT

Eligibility

Age

18 Years to 99 Years

Inclusion 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

Exclusion criteria

Exclusion criteria: 1. Patients presenting with cardiogenic shock 2. Patients with recent major bleeding complications or contraindication to DAPT, such as: a) Hypersensitivity to Aspirin, Clopidogrel, Prasugrel or Ticagrelor b) Need for oral anticoagulation c) History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia) or refusal of blood transfusions d) History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke e) Stroke or transient ischemic attack within the past 6 months or any permanent residual neurologic defect f) Gastrointestinal or genitourinary bleeding within the last 2 months or major surgery within 6 weeks g) Recent history (

Design outcomes

Primary

Measure	Time frame
All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 12 months	—

Secondary

Measure	Time frame
Bleeding (BARC II, III, V) at 12 months All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 24 months All cause mortality, MI, ST, stroke and TVR at 12 and 24 months Mortality at 12 and 24 months Cardiac Mortality at 12 and 24 months Any MI at 12 and 24 months ST at 12 and 24 months Repeat revascularization at 12 and 24 months 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 12 and 24 months Prespecified landmark analysis of Primary Endpoint (without TVR) from 3 to 12 months	—

Measure

Time frame

Bleeding (BARC II, III, V) at 12 months All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 24 months All cause mortality, MI, ST, stroke and TVR at 12 and 24 months Mortality at 12 and 24 months Cardiac Mortality at 12 and 24 months Any MI at 12 and 24 months ST at 12 and 24 months Repeat revascularization at 12 and 24 months 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 12 and 24 months Prespecified landmark analysis of Primary Endpoint (without TVR) from 3 to 12 months

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)