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.
Ischemic Heart Disease
ST-elevation Myocardial Infarction
Other: Upright position
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient|
- Change in Inhibition of ADP-receptors on thrombocytes [ Time Frame: Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100, 120 minutes post ingestion. ] [ Designated as safety issue: No ]
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.
|Study Start Date:||February 2011|
|Study Completion Date:||April 2016|
|Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
No Intervention: 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
Active Comparator: Upright administration of Efient
The test person will ingest Efient in an upright position, and remain supine during 2 hours.
Other: Upright position
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365741
|Hillerød, Denmark, 2100|
|Principal Investigator:||Jacob Antonsen, MD||Bispebjerg Hospital|