Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient
The purpose of the study is to clarify wether body posture during ingestion of 60mg Efient, a thrombocytic inhibitor, has influence on the time to thrombocytic inhibition.
The study aims to mimic the treatment Danish patients receive when admitted to the hospital with a ST-elevation myocardial infarction since these patients are refereed to acute Percutaneous Coronary Intervention (PCI) necessitating fast and efficient thrombocytic inhibition.
Current guidelines recommend the administration of Efient right before the PCI procedure, while the patient is lying down, either in the ambulance or in the operating room. We, the investigators, believe that this is suboptimal for the patient, since any sort of prolonged inhibition time will possibly worsen the patients prognosis and make the patient more prone to later clotting issues.
Our hypothesis is that by making the patients ingest the tablets in a 90 degrees upright position and making them sit up for 2 minutes after ingestion, the effect of the pills will commence faster than if taken in a supine position. This will possibly lead to faster inhibition of the thrombocytes, which we believe will lead to a lower incidence of clotting issues during and after the procedure.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
The study will be divided into two sessions: first session will be the control arm- ingestion of Efient in supine position.
14 days later, the same test-persons will be doing the intervention- ingestion of Efient sitting upright for 2 minutes. Besides this, the second session will be exactly the same as the control arm.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Hillerød, Denemarken, 2100
- Nordsjællands Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 20-30 years of age
- Healthy
- Male
- Ability to give informed consent
- Non-Smoker
Exclusion Criteria:
- Known with reflux or dysphagia
- Ingestion of medicine, beside Paracetamol <14 prior to the trial
- Hematological diseases
- Diabetes
- Known kidney disease
- Known liver disease
- Recent trauma
- Scheduled operation within 7 days after the trial
- Former apoplexia
- Known gastro-intestinal disease
- Weight <60 kg
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Standard administration of Efient
The test person will ingest Efient in supine position, and remain supine during 2 hours, mimicing the way Efient is used for pre-PCI treatment today
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Actieve vergelijker: Upright administration of Efient
The test person will ingest Efient in an upright position, and remain supine during 2 hours.
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The test person will ingest Efient in an upright position and remain upright for 2 minutes.
After 2 minutes, the test person will lie down, and remain supine for 2 hours, the same way as the person did in the control arm
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Inhibition of ADP-receptors on thrombocytes
Tijdsspanne: Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion.
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The primary outcome will be the difference between the time to sufficient/maximal inhibition of the ADP-receptors on the test-persons thrombocytes compared between supine and upright ingestion of Efient. Inhibition will be verified bedside by VerifyNow analyses. |
Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion.
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
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 (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TTISUE
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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