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.

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Key information

Conditions

Heart Disease Cardiovascular Diseases Heart Diseases Infarction Ischemia Ischemic Heart Disease Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction ST-elevation Myocardial Infarction Vascular Diseases

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nordsjællands Hospital

Hillerød, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

upright position

Other

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

Primary outcomes

Change in Inhibition of ADP-receptors on thrombocytes

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Jun 3, 2011
Registry last updated: Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed