Doelmatigheid van een op het CYP2C19 genotype gebaseerde plaatjesremmende farmacotherapie bij patienten met een myocardinfarct die worden gedotterd.

Phase 1

• Conditions: ST-segment myocardial infarction (STEMI) followed by immediate percutaneous coronary intervention with stent implantation; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-024667-40-NL
• Lead Sponsor: St. Antonius Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-04
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2700

Inclusion Criteria

1) more than 21 years of age with symptoms of acute myocardial infarction of more than 30 minutes but less than 12 hours
2) performed primary PCI with stenting for STEMI

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 1900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 800

Exclusion Criteria

1) unable to give informed consent or have a life expectancy of less than one year

2) active malignancy with increase in bleeding risk, in the investigator’s opinion

3) women who are known to be pregnant or who have given birth within the past 90 days or who are breastfeeding
4) having received thrombolytic therapy within the previous 24 hours or oral anticoagulants during the previous 7 days
5) severe renal function impairment needing dialysis
6) confirmed or persistent severe hypertension (Systolic Blood Pressure (SBP) > 180 mmHg and/or Diastolic Blood Pressure (DBP) >110 mmHg) at randomization
7) contraindication to anticoagulation or at increased bleeding risk, at the investigator’s opinion
8) cardiogenic shock (SBP = 80mmHg for >30 mins) or needing Intra-Aortic Balloon Pump (IABP)
9) history of major surgery, severe trauma, fracture or organ biopsy within 90 days prior to randomisation
10) clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator’s opinion.

Study & Design

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