Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— PLATE-BLOCK  

Official title:

Effects of Selective and Nonselective Beta-blockade on Platelet Aggregation in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809820
• Other study ID #: CE-9/14
• Status: Completed
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2022
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Carvedilol
Patients randomized to this group will receive carvedilol at the highest dose tolerated
• Metoprolol
Patients randomized to this group will receive metoprolol at the highest dose tolerated

Locations

Country	Name	City	State
Italy	Federico II University of Naples	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Bonten TN, Plaizier CE, Snoep JJ, Stijnen T, Dekkers OM, van der Bom JG. Effect of ß-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. Review. — View 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 ß-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet aggregation	Platelet aggregation induced by epinephrine is measured by Light Transmission Aggregometry (LTA)	30 days
Secondary	30-days platelet aggregation	Platelet aggregation induced by Adenosine Diphosphate (ADP) is measured by Light Transmission Aggregometry (LTA)	30 days
Secondary	30-days clinical events	Major adverse cardiac events (MACE) and bleedings will be evaluated	30 days