Heart Disease, Ischemic Heart Disease, ST-elevation Myocardial Infarction
Conditions
Keywords
PCI, STEMI, Interventions, Heart disease, Thrombocytic inhibition, Cross-over study, Percutaneous coronary intervention
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.
Interventions
OTHERUpright 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
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inhibition of ADP-receptors on thrombocytes | Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion. | 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. |
Countries
Denmark
Outcome results
None listed