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Observing Platelet Activability in a Once daily vs. a More frequent Aspirin intake regimen


- candidate number21844
- NTR NumberNTR5114
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mrt-2015
- Secondary IDsNL49455.029.14 2014-002928-27
- Public TitleObserving Platelet Activability in a Once daily vs. a More frequent Aspirin intake regimen
- Scientific TitleObserving Platelet Activability in a Once daily vs. a More frequent Aspirin intake regimen
- ACRONYMTHE OPA & OMA-TRIAL
- hypothesisA twice daily intake regimen of aspirin provides a more stable inhibition within 24 hours after intake, compared to a once daily regimen.
- Healt Condition(s) or Problem(s) studiedCardiovascular disease, Myocardial infarction, Angina Pectoris
- 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, Glanzmannís thrombasthenia and BernardĖSoulier 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. NSAIDís, tirofiban, eptifibatide, abciximab, beta-lactam antibiotics, dextran, SSRIís, clomipramine & amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, St Johnís wort).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2015
- planned closingdate1-sep-2018
- Target number of participants85
- Interventions- 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
- 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 outcomePlatelet- , reticulated platelet- , leucocyte count and haemoglobin level
- TimepointsMeasured after 10 days of every intake regimen
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jeske (J.J.K.) van Diemen
- CONTACT for SCIENTIFIC QUERIES Jeske (J.J.K.) van Diemen
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryObjective: 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.
- Main changes (audit trail)
- RECORD24-mrt-2015 - 26-jun-2017


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