Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient
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| ClinicalTrials.gov Identifier: NCT01365741 |
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Recruitment Status :
Completed
First Posted : June 3, 2011
Last Update Posted : October 2, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Disease Ischemic Heart Disease ST-elevation Myocardial Infarction | Other: Upright position | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient |
| Study Start Date : | February 2011 |
| Actual Primary Completion Date : | March 2016 |
| Actual Study Completion Date : | April 2016 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Standard administration of Efient
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
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Active Comparator: Upright administration of Efient
The test person will ingest Efient in an upright position, and remain supine during 2 hours.
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Other: Upright 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
Other Names:
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- Change in Inhibition of ADP-receptors on thrombocytes [ Time Frame: 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.
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| Ages Eligible for Study: | 20 Years to 30 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365741
| Denmark | |
| Nordsjællands Hospital | |
| Hillerød, Denmark, 2100 | |
| Principal Investigator: | Jacob Antonsen, MD | Bispebjerg Hospital |
| Responsible Party: | Jacob Antonsen, Medical Doctor, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01365741 History of Changes |
| Other Study ID Numbers: |
TTISUE |
| First Posted: | June 3, 2011 Key Record Dates |
| Last Update Posted: | October 2, 2017 |
| Last Verified: | September 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Jacob Antonsen, Rigshospitalet, Denmark:
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PCI STEMI Interventions Heart disease |
Thrombocytic inhibition Cross-over study Percutaneous coronary intervention |
Additional relevant MeSH terms:
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Infarction Heart Diseases Myocardial Infarction Myocardial Ischemia Coronary Artery Disease ST Elevation Myocardial Infarction Ischemia Pathologic Processes |
Necrosis Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Prasugrel Hydrochloride Platelet Aggregation Inhibitors |