Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01365741
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : October 2, 2017
Information provided by (Responsible Party):
Jacob Antonsen, 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.

Condition or disease Intervention/treatment Phase
Heart Disease Ischemic Heart Disease ST-elevation Myocardial Infarction Other: Upright position Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : February 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Prasugrel

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01365741

Nordsjællands Hospital
Hillerød, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Jacob Antonsen, MD Bispebjerg Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jacob Antonsen, Medical Doctor, Rigshospitalet, Denmark Identifier: NCT01365741     History of Changes
Other Study ID Numbers: TTISUE
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jacob Antonsen, Rigshospitalet, Denmark:
Heart disease
Thrombocytic inhibition
Cross-over study
Percutaneous coronary intervention

Additional relevant MeSH terms:
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Coronary Artery Disease
ST Elevation Myocardial Infarction
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors