E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Aspirin is an antiplatelet drug that affects the ability of platelets in the blood to bind together and form clots. It is used routinely in patients with or at risk of heart disease and after surgery to bypass blocked arteries supplying the heart (coronary artery bypass graft, CABG, surgery). Following CABG surgery aspirin is used to reduce the progression of fatty deposits in the arteries to the heart to help prevent bypass grafts from blocking and improve patient survival. |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect on platelet function of early high dose aspirin following Coronary Artery Bypass Grafting (CABG) compared to late low dose.
The study will compare existing practice and will not impact upon or change the prescription of the aspirin. Aspirin will be given according to randomization into the two aspirin treatment groups.
Group I: Early High Dose Regime: 300 mg Aspirin PR 4 hrs post-operatively in Cardiac Intensive Care Unit 300 mg Aspirin OD PO on each day postoperatively at the morning Discharged on 300mg OD PO
Group II: Low Dose Regime: 150 mg Aspirin OD PO from day 1 post-operatively 150 mg Aspirin OD PO on each day postoperatively at the morning Discharged on 150 mg
|
|
E.2.2 | Secondary objectives of the trial |
Secondary endpoints include the identification of aspirin related side effects, post-operative heart related complications/bleeding and recovery.
One year follow up · Death · Myocardial infarct/Angina · Stroke / TIA · PTCA / stent / re-do · Side effects of Aspirin
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients undergoing first time elective coronary artery bypass grafting only Aspirin to be stopped for at least 5 days prior to surgery
|
|
E.4 | Principal exclusion criteria |
Patients with bleeding or platelet disorders Re-do surgery Age over 80 years Emergency CABG for myocardial infarction Off pump coronary artery bypass grafting Patients stopping anti platelet therapy less then 5 days before the operation Patient taking heparin / low-molecular heparin till the day of the operation Patient stopping Warfarin less then 3 day before operation Patients with a platelet count <150 x 103/ ml Patients with Haematocrit < 35% Bleeding disorders in early postoperative period Patients with contraindications for aspirin
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the effect of aspirin on platelet function as demonstrated through the platelet function PFA 100 test. Aspirin therapy only prolongs the collagen/epinephrine closure time in the PFA 100. Col/Epi 82-150 seconds (upper limit 165 seconds). There is platelet dysfuction with a closure time of greater than 165 seconds. The closure times will be analysed with 4ml blood samples taken with citrate vacutainer system preoperatively, immediately postoperatively and at one, three and five days following surgery in accordance with routine clinical practice |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Early High Dose (300mg) Vs Late Low Dose (150mg) |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
1 year follow up for 120 patients (20 pilot study, 100 in the formal study) for every patient following coronary artery bypass grafting. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |