Cost-effectiveness of CYP2C19 genotype guided treatment with antipaletelet drugs in patients with ST-segment-elevation myocardial infarction undergoing immediate percutaneous coronary intervention with stent implantation: optimization of treatment.
- Conditions
- 10011082heart attackmyocardial infarction
- Registration Number
- NL-OMON47500
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2475
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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method