Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jacob Antonsen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01365741
First received: December 21, 2010
Last updated: April 9, 2016
Last verified: April 2016

December 21, 2010
April 9, 2016
February 2011
March 2016   (final data collection date for primary outcome measure)
Change in Inhibition of ADP-receptors on thrombocytes [ Time Frame: Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100, 120 minutes post ingestion. ] [ Designated as safety issue: No ]

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.

Change in Inhibition of ADP-receptors on thrombocytes [ Time Frame: Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100, 120 minutes post ingestion. ] [ Designated as safety issue: No ]

The primary outcome will be the difference between the time to sufficient/maximal inhibition of the ADP-receptors on the test-persons thrombocyts compared between supine and upright ingestion of Efient.

Inhibition will be verified bedside by VerifyNow analyses.

Complete list of historical versions of study NCT01365741 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Disease
  • Ischemic Heart Disease
  • ST-elevation Myocardial Infarction
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
  • 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.
    Intervention: Other: Upright position
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
April 2016
March 2016   (final data collection date for primary outcome measure)

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
Male
20 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01365741
TTISUE
Yes
Undecided
Not Provided
Jacob Antonsen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Jacob Antonsen, MD Bispebjerg Hospital
Rigshospitalet, Denmark
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP