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Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Upright position
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Disease focused on measuring PCI, STEMI, Interventions, Heart disease, Thrombocytic inhibition, Cross-over study, Percutaneous coronary intervention

Eligibility Criteria

20 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Nordsjællands Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard administration of Efient

Upright administration of Efient

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2010
Last Updated
April 13, 2019
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01365741
Brief Title
Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient
Official Title
Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Ischemic Heart Disease, ST-elevation Myocardial Infarction
Keywords
PCI, STEMI, Interventions, Heart disease, Thrombocytic inhibition, Cross-over study, Percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard administration of Efient
Arm Type
No Intervention
Arm Description
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
Arm Title
Upright administration of Efient
Arm Type
Active Comparator
Arm Description
The test person will ingest Efient in an upright position, and remain supine during 2 hours.
Intervention Type
Other
Intervention Name(s)
Upright position
Other Intervention Name(s)
Efient, Prasugrel, PCI
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Inhibition of ADP-receptors on thrombocytes
Description
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.
Time Frame
Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Antonsen, MD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nordsjællands Hospital
City
Hillerød
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30269747
Citation
Antonsen J, Bundgaard N, Holmvang L, Engstrom T, Iversen K. Posture changes platelet inhibition time after ingestion of prasugrel. Dan Med J. 2018 Oct;65(10):A5504.
Results Reference
derived
Links:
URL
http://ugeskriftet.dk/dmj/posture-changes-platelet-inhibition-time-after-ingestion-prasugrel
Description
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Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

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