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

NCT00174902 | Unknown Phase 1

• 1 other identifier: SNF 32-68277
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arteriosclerosis; Stress, Psychological

Keywords

Randomized controlled trial; Blood platelets; Hemostasis; Stress, psychological; Adrenergic beta-antagonists; Aspirin; Endothelium; Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• Change scores in plasma levels of D-dimer determined by subtracting levels immediately after the stressor as compared to baseline levels prior to the stressor.

Secondary Outcomes (4)

• Change scores of a) monocyte and T-lymphocyte expression of L-selectin, lymphocyte-function associated antigen (LFA-1), and CD40L

• monocyte tissue-factor antigen (CD 142) expression

• plasma levels of TAT, t-PA, and PAI-1

• plasma levels of soluble intercellular adhesion molecule (sICAM-1), soluble vascular adhesion molecule (sVCAM-1), endothelin-1, and vWF

Interventions

inderal (drug), acetylsalicylic acid (drug) DRUG

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Institute of Behavioral Sciences, Swiss Federal Institute of Technology

Zurich, CH-8092, Switzerland

Location

Related Publications (4)

• von Kanel R, Mills PJ, Ziegler MG, Dimsdale JE. Effect of beta2-adrenergic receptor functioning and increased norepinephrine on the hypercoagulable state with mental stress. Am Heart J. 2002 Jul;144(1):68-72. doi: 10.1067/mhj.2002.123146.

  PMID: 12094190 BACKGROUND

• Mischler K, Fischer JE, Zgraggen L, Kudielka BM, Preckel D, von Kanel R. The effect of repeated acute mental stress on habituation and recovery responses in hemoconcentration and blood cells in healthy men. Life Sci. 2005 Jul 22;77(10):1166-79. doi: 10.1016/j.lfs.2005.03.006. Epub 2005 Apr 26.

  PMID: 15978266 RESULT

• von Kanel R, Kudielka BM, Preckel D, Hanebuth D, Fischer JE. Delayed response and lack of habituation in plasma interleukin-6 to acute mental stress in men. Brain Behav Immun. 2006 Jan;20(1):40-8. doi: 10.1016/j.bbi.2005.03.013.

  PMID: 15890495 RESULT

• von Kanel R, Preckel D, Zgraggen L, Mischler K, Kudielka BM, Haeberli A, Fischer JE. The effect of natural habituation on coagulation responses to acute mental stress and recovery in men. Thromb Haemost. 2004 Dec;92(6):1327-35. doi: 10.1160/TH04-04-0223.

  PMID: 15583741 RESULT

MeSH Terms

Conditions

Arteriosclerosis; Stress, Psychological

Interventions

Propranolol; Pharmaceutical Preparations; Aspirin

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives

Study Officials

• Joachim E Fischer, MD, MSc

  Swiss Federal Institute of Technology, Institute of Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2003
• Study Completion: August 1, 2004
• Last Updated: October 25, 2006

Record last verified: 2003-10

Locations

CH (1)