- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01248351
Reversibility of Dual Antiplatelet Therapy by Platelets
Reversibility of Dual Antiplatelet Therapy by Platelets.Phase II Study
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Dual antiplatelet therapy with aspirin and clopidogrel is a well established strategy to prevent thrombotic complications in patients with high platelet reactivity following plaque rupture in acute coronary syndromes (ACS) or percutaneous coronary interventions. Current practice guidelines for antiplatelet therapy advocate a one to 12 months dual antiplatelet therapy after bare metal stent PCI and a 12 months dual antiplatelet therapy after PCI in patients with ACS and drug eluting stent PCI. Although oral antiplatelet therapy is associated with both, short- as well as long-term clinical efficacy, irreversible platelet inhibition carries a substantial risk of bleeding particularly in patients presenting for surgery. Empiric therapy of bleeding consists of platelet transfusion. However, there are currently no pharmacodynamic studies assessing the effect of stored platelets on in-vitro platelet function tests.
Healthy volunteers will donate platelets, take aspirin and clopidogrel for 3 days (loading dose aspirin 300 mg, clopidogrel 300 mg, maintenance dose aspirin 100 mg, clopidogrel 75 mg) and platelets will be retransfused on the 4th day. Pharmacodynamic measurements of platelet function will be performed at baseline, after drug intake before retransfusion, immediately after retransfusion and 24 hours thereafter.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
-
-
-
Graz, Oostenrijk, 8036
- Department of anesthesia and intensive care medicine, Medical Univerity of Graz
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Informed consent
- Healthy volunteers, male or female (after exclusion of pregnancy if they are on birth control pill or have a contraceptive coil implanted)
- Age of consent
- Weight: 70 kg - 100 kg
- Platelet count 240 000 to 440 000/µL
- Hematocrit > 40%
- readiness to refrain from any activities prone to injury during the study period.
Exclusion criteria:
- Allergy against aspirin or clopidogrel
- History of bleeding
- History of peptic ulcer
- Intake of aspirin or NSAR during the last ten days before screening
- Gastrointestinal disease precluding resorption of aspirin and clopidogrel
- Scheduled surgery
- Any current medication
- History of hepatic disease
- 20µm ADP induced aggregation < 60% at screening
- CYP2C19 polymorphisms
- Donation of blood within the preceding 4 weeks
- Neurotic disease
- Current smoking
- Drug addiction
- Intake of grapefruits during the last 10 days before
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: autologous stored platelets
|
Administration of autologous stored platelets
administration of autologous stored platelets
transfusion of autologous stored platelets
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Pharmacodynamic assessment of platelet function as assessed by 5 and 20 micromolar ADP
Tijdsspanne: 7 days
|
pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
|
7 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Pharmacodynamic assessment of platelet function as assessed by 20 mM arachidonic acid
Tijdsspanne: 7 days
|
pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
|
7 days
|
Pharmacodynamic assessment of platelet function as assessed by Vasodilator stimulated phosphoprotein (VASP) phosphorylation (platelet reactivity index; PRI)
Tijdsspanne: 7 days
|
pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
|
7 days
|
Pharmacodynamic assessment of platelet function as assessed by expression of GP IIb/IIIa receptors and P-selectin (Mean fluorescence intensity %)
Tijdsspanne: 7 days
|
pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
|
7 days
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mahla Elisabeth, MD, Dept. of Anesthesia and Intensive Care Medicine, Medical University of Graz
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- PAC_2009
- 2009-018108-17 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op autologous stored platelets
-
University of FloridaVoltooidHoofd- en nekaandoening | Gratis klepVerenigde Staten
-
Womack Army Medical CenterUniformed Services University of the Health Sciences; The Geneva FoundationWervingFacetgewrichtspijn; Onderrug pijnVerenigde Staten
-
University of Rome Tor VergataVoltooidMesenchymale stamcellen | Graft vs Host-ziekte | Orale mucositis (ulceratief)Italië
-
University of California, San DiegoWervingOsteo artritis knieVerenigde Staten
-
Assistance Publique - Hôpitaux de ParisBeëindigdCardiopulmonale bypassFrankrijk
-
University of Southern CaliforniaBeëindigdTandvleesrecessieVerenigde Staten
-
Gazi UniversityVoltooidTandvleesrecessie
-
Armed Police Force Hospital, NepalVoltooidFasciitis plantaris | Steroïde | Bloedplaatjesrijk plasma (PRP)Nepal
-
University Hospital, MontpellierNog niet aan het wervenHartoperatie | Cardiopulmonale bypass | CoagulopathieFrankrijk
-
Maharishi Markendeswar University (Deemed to be...VoltooidBotverlies | Chronische parodontitis | Intrabony parodontaal defectIndië