Randomized controlled trial of Stopping Perioperative Angiotensin-II Converting Enzyme inhibitors and/or Angiotensin Receptor Blockers in major noncardiac surgery.
- Conditions
- Myocardial injury (as measured by plasma troponin) after major surgery.MedDRA version: 20.0 Level: PT Classification code 10061024 Term: Cardiac disorder System Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-004141-90-GB
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 260
• Informed consent (no incapacitated or vulnerable adult or minors will be included).
• Age 60 years and over.
• Undergoing major surgery (major joint replacement/ vascular/ gastrointestinal) requiring general and/or regional anaesthesia with sedation.
• Currently taking ACE-I, ARB or combined ACE-I and ARB therapy.
• Duration of surgery longer than 120 minutes.
• ASA grade 3 or above.
• All female subjects must be postmenopausal, as demonstrated by clinical history or demonstrated not to be pregnant though a preoperative pregnancy test.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160
• Current participation in any other trials where care or treatment is being altered.
• Recent myocardial infarction (within 3 months).
• Any condition, which in the opinion of the treating clinician would result in the patient being harmed by the cessation of the ACE-I and/or ARB therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method