Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

Rigshospitalet

Status: Completed

Conditions: Ischemic Heart Disease; ST-elevation Myocardial Infarction; Heart Disease

Treatments: Other: Upright position

Study type: Interventional

Funder types: Other

Identifiers

NCT01365741

TTISUE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 20 to 30 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Standard administration of Efient

No Intervention group

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

Upright administration of Efient

Active Comparator group

Description:

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

Treatment:

Other: Upright position