The Effect of Beta-Blockers and Aspirin on Hemostasis and Endothelial Function After Acute Mental Stress

• Status: Unknown status
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized double-blinded controlled trial uses a factorial design to investigate whether application of beta-blockers (inderal 80 mg) or aspirin (100 mg) or a combination thereof has an effect on the activation of the hemostatic system, the platelets and the endothelium in response to acute mental stress. Specifically we test the hypothesis that inderal attenuates the activation of the hemostatic system as compared to placebo. The second hypothesis is that aspirin attenuates the activation of platelets as compared to placebo. Subjects will be randomly allocated to either of the four following study arms: placebo - inderal - aspirin - inderal plus aspirin. Subjects will receive the study medication for five days prior to the mental stress. The acute mental stress consists of a public speaking session of 10 min duration immediately followed by a mental arithmetic test of 5 min duration. Blood will be collected prior to the stress, immediately thereafter, at 45 min at at 1 hour and 45 min.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Swiss Federal Institute of Technology
• Collaborator: Swiss National Science Foundation
• Treatments: Adrenergic beta-Antagonists; Aspirin; Propranolol

Criteria

Inclusion Criteria:

• Life-time non-smoker or non-smoker for more than a year,

• native language Swiss-German,

• systolic blood pressure <160 mm Hg, diastolic blood pressure <100 mm Hg.

• Subjects must have a body mass index that is not considered to be a cardiovascular risk factor, i.e. ≤ 26.5 kg/m2.

Exclusion Criteria:

• Individuals reporting cardiovascular disease, renal disorders, endocrine disorders, hepatopathy, psychiatric disorders or who take regular medication for any of these conditions.

• Persons are excluded, who report to drink >5 cups (0.15 l each) of brewed coffee (> 500 mg caffeine) a day, or who report drink more than 1.0 l beer and 0.45 l wine per day, respectively.

• All subjects on regular beta-blocking or aspirin medication are excluded from the study.

• Participants will be required not to take aspirin or any other non-steroidal anti-inflammatory drug during the study period, beginning 10 days prior to the first study medication.