Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Study Overview
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Brief Summary
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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
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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.

Official Title
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Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Conditions
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Heart Disease, Ischemic Heart Disease, ST-elevation Myocardial Infarction

Intervention / Treatment
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* Other: Upright position


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard administration of Efient<br>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<br>The test person will ingest Efient in an upright position, and remain supine during 2 hours. | Other: Upright position<br>* 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<br>* Other names: PCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Inhibition of ADP-receptors on thrombocytes | 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. | Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, STEMI, Interventions, Heart disease, Thrombocytic inhibition, Cross-over study, Percutaneous coronary intervention