NCT01365741

Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: Male
• Age: 20 Years – 30 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Disease
• Ischemic Heart Disease
• ST-elevation Myocardial Infarction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-02-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2011-06-03
• Last updated: 2019-04-16

Locations

1 site across 1 country: Denmark