E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stable cardiovascular disease |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
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 |
Analyzing whether a twice daily regimen is superior to a once daily regime of aspirin when it comes to inhibiting platelet aggregation in cardiovascular patients |
|
E.2.2 | Secondary objectives of the trial |
To identify patient characteristics with an increased attenuation of platelet inhibition by aspirin over the course of 24 hours |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Outpatients being treated for stable cardiovascular disease
by the cardiology department.
• Stable cardiovascular disease defined as: coronary artery disease, peripheral vascular disease or previous myocardial infarction.
• Intake of 80 mg of acetylsalicylic acid once a day.
|
|
E.4 | Principal exclusion criteria |
• Active bleeding
• Diabetes mellitus
• Thrombocytopenia
• Thrombocytosis
• Thrombopathy (e.g. von Willebrand disease, Glanzmann’s thrombasthenia and Bernard–Soulier syndrome)
• Any ischemic event or revascularization procedure (percutaneous coronary intervention or coronary artery bypass grafting) within the last six months.
• Alcohol intake the day before blood sampling.
• Non-compliance to the protocol
• Baxter rolls (i.e. presorted medicine by a pharmacist)
• Recent use of antiplatelet drugs, anticoagulants or drugs that are known to alter platelet function, other than aspirin (e.g. NSAID’s, tirofiban, eptifibatide, abciximab, beta-lactam antibiotics, dextran, SSRI’s, clomipramine & amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, St John’s wort).
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
PFA-200 parameters: closure time, flow slope, maximum rate of occlusion and area under the curve
Chrono-log LTA parameters: Amplitude of aggregation given in percentages and the area under the curve.
VerifyNow parameter: PRU
TBX2 serum levels.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After enrollment, during experiments, 6 times in total |
|
E.5.2 | Secondary end point(s) |
Platelet- , reticulated platelet- , leucocyte count and haemoglobin level |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After enrollment, during experiments |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
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 |
No cardiovascular disease |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
|
last visit of the last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |