Testing the responsiveness of patients admitted to intensive care units to treatment with anti-platelet drugs (acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor)

Phase 1

• Conditions: mixed medical intensive care unit patients; MedDRA version: 20.0Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2012-002226-76-AT
• Lead Sponsor: Medical University of Vienna, Department of Clinical Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-03
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 262

Inclusion Criteria

=18years of age
Admittance to an ICU
pretreatment with Acetylsalicylic acid, clopidogrel, prasugrel or pantoprazole
ex-vivo study: Acute Myocardial infarction
ex vivo study(2): =18years of age
Admittance to an ICU
pretreatment with clopidogrel, prasugrel or ticagrelor
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Recent surgery
Active bleeding
Known coagulation disorders
Discretion of the physician
Terminal illness (anticipated life expectancy <3months; e.g. due to cancer)
ex-vivo study: thrombocytopenia
ex-vivo study(2): thrombocytopenia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified