Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Disease; Ischemic Heart Disease; Percutaneous Coronary Intervention; ST-elevation Myocardial Infarction; Thrombocytic Inhibition
Intervention: Upright position (Other)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Rigshospitalet, Denmark Official(s) and/or principal investigator(s): Jacob Antonsen, Medical Doctor, Principal Investigator, Affiliation: Rigshospitalet, Denmark
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.
Clinical Details
Official title: Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Inhibition of ADP-receptors on thrombocytes
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
Minimum age: 20 Years.
Maximum age: 30 Years.
Gender(s): Male.
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
Locations and Contacts
Nordsjællands Hospital, Hillerød 2100, Denmark
Additional Information
Starting date: February 2011
Last updated: October 23, 2013
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