A Study of the Effect of Epinephrine on Platelet Reactivity in Subjects Treated With Ticagrelor

• Status: Completed
• Trial end date: 2018-03-28
• Target enrollment: 0
• Participant gender: Male

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 volunteers who have received ticagrelor. Volunteers fulfilling all of the inclusion and none of the exclusion criteria will be included. Enrollment will be continued until the required sample size is achieved (10 subjects).

Once informed consent is obtained, screening data will be collected to determine each subject's eligibility for study participation. The total expected duration of subject participation is 18 days, from screening visit to end of follow-up. The active participation is 8h (study procedure 4 hours, observation period 4 hours).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vastra Gotaland Region
• Collaborators: Gothia Forum; Gothia Forum - Center for Clinical Trial; Uppsala University
• Treatments: Epinephrine; Epinephryl borate; Metoprolol; Racepinephrine; Ticagrelor

Criteria

Inclusion Criteria:

1. Signed informed consent,

2. Males of age 18-40 years

Exclusion Criteria:

1. Any chronic physical or mental disease or disorder

2. Chronic medication of any kind

3. 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.

4. 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.

5. 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.

6. Non-willingness to refrain from caffeine intake or nicotine use within 24 hours before start of treatment

7. Simultaneous participation in any other clinical study

8. 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

9. Known intolerance or contraindication to ticagrelor, adrenaline or metoprolol

10. Any disorder that may interfere with drug absorption

11. Previous intracranial bleeding

12. Any condition that in the opinion of the investigator may interfere with adherence to trial protocol