Clinical trial NCT02809820: Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome
Official title: Effects of Selective and Nonselective Beta-blockade on Platelet Aggregation in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: ACS
Beta Blockers
platelet aggregation
light transmission aggregometry
Beta-Adrenergic Blockers
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The Investigators will test the hypothesis that nonselective beta-blockers would have a more pronounced effect on platelet aggregation than selective beta-blockers in patients with acute coronary syndrome treated with dual anti platelet therapy.

Detailed description: In patients with acute coronary syndrome (ACS) beta-blockers are recommended for secondary prevention. It is known that catecholamine levels can potentiate platelet reactivity and beta-blocking agents may also affect platelet aggregation. This effect is mainly mediated by adrenergic receptors on platelets. This suggests that nonselective beta-blockers would have a more pronounced effect on platelet aggregation than selective beta-blockers. However, little is known about the effect of beta-blockers on platelet aggregation in patients with cardiovascular disease and, to date, nothing is known in the setting of ACS.

The aim of the present study is to evaluate the effect of selective and nonselective beta-blockers on platelet aggregation in ACS patients treated with dual anti platelet therapy.

Eligibility criteria: Inclusion Criteria:

* Acute Coronary Syndrome
* Current dual anti platelet treatment with acetylsalicylic acid and Ticagrelor

Exclusion Criteria:

* ongoing prasugrel, ticlopidine or clopidogrel therapy
* Creatinine Clearance \< 30 ml/min/1.73mm2
* Moderate to severe anemia Hemoglobin \< 10 mg/dl
* Platelet count \>600000/mm3 or \<150000/mm3 or hematocrit \>50% or \<25%
* concomitant neoplastic or immune-mediated pathologies
* severe pulmonary pathologies
* contraindication to beta blocker therapy.

Primary outcomes:
measure: Platelet aggregation
timeFrame: 30 days
Secondary outcomes:
measure: 30-days platelet aggregation
timeFrame: 30 days
measure: 30-days clinical events
timeFrame: 30 days
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University of Naples
Study officials:
affiliation: Federico II University
name: Giovanni Esposito, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonten TN, Plaizier CE, Snoep JJ, Stijnen T, Dekkers OM, van der Bom JG. Effect of beta-blockers on platelet aggregation: a systematic review and meta-analysis. Br J Clin Pharmacol. 2014 Nov;78(5):940-9. doi: 10.1111/bcp.12404.
citation: Ignjatovic V, Pavlovic S, Miloradovic V, Andjelkovic N, Davidovic G, Djurdjevic P, Stolic R, Iric-Cupic V, Simic I, Ignjatovic VD, Petrovic N, Smiljanic Z, Zdravkovic V, Simovic S, Jovanovic D, Nesic J. Influence of Different beta-Blockers on Platelet Aggregation in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy. J Cardiovasc Pharmacol Ther. 2016 Jan;21(1):44-52. doi: 10.1177/1074248415581175. Epub 2015 Apr 13.