Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-04-30

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.

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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.

Conditions

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Heart Disease Ischemic Heart Disease ST-elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

Upright administration of Efient

The test person will ingest Efient in an upright position, and remain supine during 2 hours.

Group Type ACTIVE_COMPARATOR

Upright position

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Efient Prasugrel PCI

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes