None listed
Conditions
Brief summary
This research project is designed to assess the response to a drug known as Plavix®. This drug reduces blood clotting by acting on small blood cells called platelets. A platelet rich blood clot is the cause of the blockage of the arteries of the heart that causes a heart attack. This study will hopefully determine the ideal dose that will give the maximum effect on clotting and help reduce the heart attacks related to the stenting opening of the heart arteries. We will also learn whether a drug called verapamil, given at the time of stenting has any effect on the clotting properties of Plavix®. Research assessing this drug interaction and higher doses of Plavix® has not been undertaken before. Both patients and investigators will be blinded to treatment allocation. One randomisation occurs at the outset, to one of four arms. Each study drug administered is coded to blind subjects and investigators.
Interventions
Patients will be randomised to receive intravenously verapamil 5mg, orally 600mg clopidogrel or 1,200mg clopidogrel (split dose 600mg followed by 600mg 2 hours later, whilst in hospital). The drug effects will be monitored by platelet function analysis. Patients at discharge will be randomised to 75mg daily or 150mg daily of clopidogrel and platelet function measured at one week. Patients will receive standard dose clopidogrel 75mg once daily for either 3 weeks or 6 months depending on whether
Patients will be randomised to receive intravenously verapamil 5mg, orally 600mg clopidogrel or 1,200mg clopidogrel (split dose 600mg followed by 600mg 2 hours later, whilst in hospital). The drug effects will be monitored by platelet function analysis. Patients at discharge will be randomised to 75mg daily or 150mg daily of clopidogrel and platelet function measured at one week. Patients will receive standard dose clopidogrel 75mg once daily for either 3 weeks or 6 months depending on whether they receive bare metal coronary stents or drug eluting stents respectively.
Sponsors
Auckland City Hospital.
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
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.
Outcome results
None listed