Status:
COMPLETED
A Study of the Effect of Epinephrine on Platelet Reactivity in Subjects Treated With Ticagrelor
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Gothia Forum - Center for Clinical Trial
Uppsala University
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
The study is an experimental observational study in ten healthy volunteers. Based on an in vitro study, it is hypothesize that a low dose epinephrine infusion will improve platelet function in healthy...
Detailed Description
The study is an experimental observational study in ten healthy volunteers. Volunteers fulfilling all of the inclusion and none of the exclusion criteria will be included. Enrollment will be continued...
Eligibility Criteria
Inclusion
- Signed informed consent,
- Males of age 18-40 years
Exclusion
- Any chronic physical or mental disease or disorder
- Chronic medication of any kind
- Any occasional doses of the following substances at least one week before the investigation due to potential interactions with ticagrelor: ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, rifampicin, fenitoin, carbamazepin, pentobarbital , cyclosporine, verapamil, diltiazem, kinidin, heparin, enoxaparin, acetylsalicylic acid, desmopressin, digoxin, beta-blockers (e.g. metoprolol, atenolol , bisoprolol) and selective serotonin reuptake inhibitors (SSRI) (e.g. paroxetine, sertraline, citalopram). In addition non-steroidal anti-inflammatory drugs (NSAIDS) should be avoided due to an increased risk of bleeding.
- Any occasional doses of the following substances at least one week before the investigation due to potential interactions with adrenalin: Beta-blockers ((e.g. metoprolol, atenolol , bisoprolol), tricyclic antidepressants (e.g protriptyline, maprotilin), digoxin and kinidin.
- Any occasional doses of the following substances at least one week before the investigation due to potential interactions with metoprolol: Calcium-antagonists (verapamil, diltiazem, nifedipine), anti-arrythmics (e.g disopyramide), insulin, tricyclic antidepressants (e.g protriptyline, maprotilin), barbiturates; fentiazins and nitroglycerine.
- Non-willingness to refrain from caffeine intake or nicotine use within 24 hours before start of treatment
- Simultaneous participation in any other clinical study
- Known drug abuse of any kind, or other condition that may render the subject more likely to be non-compliant to the protocol, as judged by the investigator
- Known intolerance or contraindication to ticagrelor, adrenaline or metoprolol
- Any disorder that may interfere with drug absorption
- Previous intracranial bleeding
- Any condition that in the opinion of the investigator may interfere with adherence to trial protocol
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03441412
Start Date
February 28 2018
End Date
March 28 2018
Last Update
May 11 2018
Active Locations (1)
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1
gothia Forum CTC
Gothenburg, Sweden, 41345