Clinical trial NCT01365741: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Disease
Ischemic Heart Disease
ST-elevation Myocardial Infarction
Keywords: PCI
STEMI
Interventions
Heart disease
Thrombocytic inhibition
Cross-over study
Percutaneous coronary intervention
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Inhibition of ADP-receptors on thrombocytes
timeFrame: Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion.
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Jacob Antonsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.