No registrations found.
ID
Source
Brief title
Health condition
Cardiovascular patients myocardial infarcation angina pectoris
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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.
Secondary outcome
Platelet- , reticulated platelet- , leucocyte count and haemoglobin level
Background summary
Objective: Analyze whether a twice daily regimen is superior to a once daily regime of aspirin when it comes to inhibiting platelet aggregation in cardiovascular patients
Study design: Single blinded, open label, randomized cross-overy study.
Study population: 75 outpatients from the cardiology department, taking 80 mg of acetylsalicylic acid once a day. 10 healthy subjects will be used to define baselines in the assays that are being used.
Intervention: Study participants will sequentially be allocated to three dosage regimens, A1, B, and C. The order of allocation will be decided via randomisation. Regimen A and B are designed to establish a baseline activability of the platelets under a once a day regime of acetylsalicylic acid. In regimen C participants are put on a twice daily dosage regimen. NB circadian rhythm has been taken into account. .
Main study parameters/endpoints: We will analyze whether a twice daily regimen is superior to a once daily regime of aspirin when it comes to inhibiting platelet aggregation in cardiovascular patients, as measured by the PFA-200, Chrono-log light transmission aggregometry, VerifyNow, and a TBX2 serum ELISA.
Study objective
A twice daily intake regimen of aspirin provides a more stable inhibition within 24 hours after intake, compared to a once daily regimen.
Study design
Measured after 10 days of every intake regimen
Intervention
- Once daily intake regime 8.00 am, duration 10 days
- Once daily intake regime 8.00 pm, duration 10 days
- Twice daily intake regime 8.00 am & pm, duration 10 days
Jeske (J.J.K.) van Diemen
Amsterdam 1081 HV
The Netherlands
0031630179557 / 0630179557
jj.vandiemen@vumc.nl
Jeske (J.J.K.) van Diemen
Amsterdam 1081 HV
The Netherlands
0031630179557 / 0630179557
jj.vandiemen@vumc.nl
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.
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
- 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).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4976 |
| NTR-old | NTR5114 |
| CCMO | NL49455.029.14 |
| OMON | NL-OMON42162 |