Ticagrelor for the Comatose
TICOMA
The Effect of Antithrombotic Treatment Administrated Through Nasogastric Tubes to Comatose Patients Undergoing Acute Percutaneous Coronary Intervention
2 other identifiers
observational
47
1 country
1
Brief Summary
The study will investigate the effect of the oral antiplatelet agent ticagrelor (Brilique) when it is administrated through a nasogastric tube in comatose patients. The platelet function can be determined by various platelet function tests (PFT), Multiplate and VerifyNow . As control, the reference intervals from the literature are used. Futhermore, plasma concentrations of the active metabolite will be determined at aeveral timepoints after first intake of a bolus dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2014
CompletedFirst Posted
Study publicly available on registry
June 26, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedApril 7, 2016
April 1, 2016
1 year
June 25, 2014
April 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Platelet inhibition measured by VerifyNow at 12 hours
12 hours after ticagrelor bolus
Secondary Outcomes (1)
Platelet inhibition at several time points by VerifyNow and Multiplate
2hours to 5 days after admission
Other Outcomes (1)
Plasma concentration of active drug and parent compound
2 hours to 5 days
Study Arms (1)
comatose patients
180 mg ticagrelor followed by 90 mg BID for comatose patients after cardiac arrest
Eligibility Criteria
The study population consists of 50 unconscious patients, primary due to cardiac arrest or cardiogenic shock. All patients have been undergoing recent percutaneous coronary intervention (PCI) and are hospitalized at the cardiac intensive care unit.
You may qualify if:
- Recent (\<3 hours) PCI and therefore indication for oral ADP inhibitor treatment
- The patient is in a condition that disables normal oral administration of tablets and requires naso-gastric tube insertion.
You may not qualify if:
- Age \< 18 years old
- Serious bleeding tendency, absolute contraindication to antithrombotic treatment (as defined in product information)
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lene Holmvanglead
- AstraZenecacollaborator
Study Sites (1)
Rigshospitalet
Copenhagen O, 2100, Denmark
Biospecimen
plasma and urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lene Holmvang, MD, PHD
Rigshospitalet, Denmark
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 25, 2014
First Posted
June 26, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
April 7, 2016
Record last verified: 2016-04