Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient

NCT01365741 | Completed DMC

• 1 other identifier: TTISUE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

PCI; STEMI; Interventions; Heart disease; Thrombocytic inhibition; Cross-over study; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  Blood will be drawn from the test person at 0, 20, 40, 60, 80, 100minutes post ingestion.

Study Arms (2)

Standard administration of Efient

NO INTERVENTION

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

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

Other: Upright position

Interventions

Upright position OTHER

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

Also known as: Efient, Prasugrel, PCI

Upright administration of Efient

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Healthy
• Male
• Ability to give informed consent
• Non-Smoker

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Nordsjællands Hospital

Hillerød, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30269747 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Heart Diseases; Myocardial Ischemia; ST Elevation Myocardial Infarction

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jacob Antonsen, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: June 3, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

DK (1)