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Evaluation of safety and efficacy of two ticagrelorbased de-escalation antiplatelet strategies in acute coronary syndrome: the randomized, multicenter, double-blind ELECTRA RCT study.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518090-34-00
Acronym
2019/ABM/01/00009
Enrollment
4500
Registered
2024-11-24
Start date
2022-02-07
Completion date
Unknown
Last updated
2024-11-24

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

Conditions

Acute Coronary Syndrom (ACS)

Brief summary

The primary end point os this project is the first occurrence of type 2, 3 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) criteria, within 12 months of observation, in a time-to-event analysis. BARC type 2 bleeding is any clinically overt sign of haemorrhage that is actionable and requires diagnostic studies, hospitalization, or treatment by a health care professional., BARC type 3 bleeding is: a) overt bleeding with haemoglobin drop of 3 to <5 g/dL (provided it is related to bleed); transfusion with overt bleeding;, b) overt bleeding with hemoglobin drop ≥5 g/dL (provided it is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents;c) intracranial haemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision., BARC type 5 bleeding is fatal bleeding.

Detailed description

BARC type 3 or 5 bleeding, Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) moderate, severe, or life-threatening bleeding;, International Society of Thrombosis and Haemostasis (ISTH) major bleeding, death from any cause, death from Cardiovascular causes (CV);, myocardial infarction, ischemic stroke, definite or probable stent thrombosis, adherence to study treatment, dyspnea

Interventions

DRUGBrilique 90 mg orodispersible tablets
DRUGASPIRIN CARDIO
DRUG100 mg
DRUGMicrocrystalline cellulose
DRUGcorn starch Coating: copolymer of methacrylic acid and methyl acrylate
DRUGtalc and triethyl citrate

Sponsors

Nicolaus Copernicus University
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
BARC type 3 or 5 bleeding, Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) moderate, severe, or life-threatening bleeding;, International Society of Thrombosis and Haemostasis (ISTH) major bleeding, death from any cause, death from Cardiovascular causes (CV);, myocardial infarction, ischemic stroke, definite or probable stent thrombosis, adherence to study treatment, dyspnea

Primary

MeasureTime frame
The primary end point os this project is the first occurrence of type 2, 3 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) criteria, within 12 months of observation, in a time-to-event analysis. BARC type 2 bleeding is any clinically overt sign of haemorrhage that is actionable and requires diagnostic studies, hospitalization, or treatment by a health care professional., BARC type 3 bleeding is: a) overt bleeding with haemoglobin drop of 3 to <5 g/dL (provided it is related to bleed); transfusion with overt bleeding;, b) overt bleeding with hemoglobin drop ≥5 g/dL (provided it is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents;c) intracranial haemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision., BARC type 5 bleeding is fatal bleeding.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026