Plavix response in coronary intervention (PRINC)
Phase 4
- Conditions
- Coronary artery diseaseCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12606000129583
- Lead Sponsor
- Auckland City Hospital.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
1. Signed informed consent2. All-comers (male and female of any age) with coronary disease on aspirin scheduled for elective PCI
Exclusion Criteria
1. A bleeding or platelet disorder2. Previous gastrointestinal bleeding or gastric ulcer/duodenal ulcer/gastritis3. Sensitivity/allergy to aspirin or clopidogrel or verapamil4. Renal failure Cr >0.12mmol/L 5. Anaemia Hb <115mg/dL6. Medication inhibiting CYP3A4.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Platelet function measured by VerifyNow? (Accumetrics Ltd) P2Y12 platelet function analyzer[At 2, 4, 7 hours and 7 days from Percutaneous Coronary Intervention (PCI)];Peak troponin, Creatinine Kinase (CK)[At 4 and 7 hours from PCI.]
- Secondary Outcome Measures
Name Time Method Complications associated with PCI i.e. Vascular complications; <br>1. Haematoma<br>a. Assessed by clinical examination immediately prior to discharge.<br>2. Pseudoaneurysm <br>a. Diagnosed by vascular ultrasound. Ultrasound will be performed in any patient with a haematoma greater than 10cm in its largest dimension or any tender swellings in which the attending clinician has a high suspicion on pseudoaneurysm.<br>3. Retroperitoneal haemorrhage<br>a. Diagnosed by CT scan of the pelvis. CT will be perfomed it the haemoglobin drops unexpectedly or if the patient becomes shocked without cardiac cause.[];Adverse drug reactions; <br>1. nausea, vomiting, rash, haematological dyscrasia.<br>P2Y12 receptor genetic haplotypes[]