Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jacob Antonsen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01365741
First received: December 21, 2010
Last updated: October 23, 2013
Last verified: October 2013
History of Changes
  Purpose

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 Intervention
Heart Disease
Ischemic Heart Disease
Percutaneous Coronary Intervention
ST-elevation Myocardial Infarction
Thrombocytic Inhibition
 Other: Upright position

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Resource links provided by NLM:

Drug Information available for: Prasugrel
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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.
Enrollment: 10
Study Start Date: February 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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

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.

  Eligibility
Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365741

Locations
Denmark
Nordsjællands Hospital
Hillerød, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Jacob Antonsen, Medical Doctor Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Jacob Antonsen, Medical Doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01365741     History of Changes
Other Study ID Numbers: TTISUE
Study First Received: December 21, 2010
Last Updated: October 23, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
PCI
STEMI
Interventions
Heart disease
 Thrombocytic inhibition
Cross-over study
Percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
 Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015