Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01365741

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease Ischemic Heart Disease ST-elevation Myocardial Infarction	Other: Upright position	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Other Names: Efient Prasugrel PCI

Arm

Intervention/Treatment

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

Other Names:

Efient

Prasugrel

PCI

Outcome Measures

Primary Outcome Measures

Change in Inhibition of ADP-receptors on thrombocytes [Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion.]
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.