Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Not Applicable

Completed

• Conditions: Heart Disease; ST-elevation Myocardial Infarction; Ischemic Heart Disease
• Interventions: Other: Upright position

• Registration Number: NCT01365741
• Lead Sponsor: Rigshospitalet, Denmark

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.

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 Timeline

• Study First Submitted: 2010-12-21
• Study Start: 2011-02
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-13
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Upright administration of Efient	Upright position	The test person will ingest Efient in an upright position, and remain supine during 2 hours.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nordsjællands Hospital; 🇩🇰 Hillerød, Denmark