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

Observing Platelet Activability in a Once daily vs. a More frequent Aspirin intake regimen - OPA- & OMA-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42162
Enrollment
85
Registered
2015-01-29
Start date
2016-08-24
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial infarction Heart attack

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Active bleeding - Diabetes mellitus - Thrombocytopenia - Thrombocytosis - Valvualar heart disease/dysfunction - 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). ;

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Platelet- , reticulated platelet- , leucocyte count and haemoglobin level as a possible effect modifying parameter.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)