Acute Coronary SyndromePhase 4PLATE-BLOCKNCT02809820
Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome
A Phase 4 study testing Carvedilol and Metoprolol in people with Acute Coronary Syndrome, run by Federico II University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Carvedilol and Metoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- May 2016to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Coronary Syndrome
- Current dual anti platelet treatment with acetylsalicylic acid and Ticagrelor
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Selective and Nonselective Beta-blockade on Platelet Aggregation in Patients With Acute Coronary Syndrome
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Carvedilol, Metoprolol
- Keywords
- ACS, Beta Blockers, platelet aggregation, light transmission aggregometry, Beta-Adrenergic Blockers
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Also called Selective beta-blocker
Patients randomized to this group will receive carvedilol at the highest dose tolerated
MetoprololDrug
Also called Non Selective beta-blocker
Patients randomized to this group will receive metoprolol at the highest dose tolerated
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol | Active comparator | Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume carvedilol. Receives: Drug: Carvedilol |
| Metoprolol | Active comparator | Patients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume metoprolol. Receives: Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation
Platelet aggregation induced by epinephrine is measured by Light Transmission Aggregometry (LTA)
Measured: 30 days
Secondary outcomes (2)
30-days platelet aggregation
Platelet aggregation induced by Adenosine Diphosphate (ADP) is measured by Light Transmission Aggregometry (LTA)
Measured: 30 days
30-days clinical events
Major adverse cardiac events (MACE) and bleedings will be evaluated
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Esposito, Federico II University
- Investigators
- Giovanni Esposito, MD PhD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809820
- Sponsor's protocol ID
- CE-9/14
- Acronym
- PLATE-BLOCK
- Status last verified
- Mar 2022
- First submitted
- 20 Jun 2016
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24730697Ignjatovic 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.
PubMed 25868659
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Selective and Nonselective Beta-blockade on Platelet Aggregation in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02809820
- Acronym / sponsor ID
- PLATE-BLOCK / CE-9/14
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS, Beta Blockers, platelet aggregation, light transmission aggregometry, Beta-Adrenergic Blockers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol | Active comparator | Drug: CarvedilolPatients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume carvedilol. |
| Metoprolol | Active comparator | Drug: MetoprololPatients who have documented ACS, who are on dual antiplatelet therapy and are randomized to assume metoprolol. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute Coronary Syndrome
- Current dual anti platelet treatment with acetylsalicylic acid and Ticagrelor
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarvedilolAlso: Selective beta-blockerPatients randomized to this group will receive carvedilol at the highest dose tolerated | Drug | Carvedilol |
| MetoprololAlso: Non Selective beta-blockerPatients randomized to this group will receive metoprolol at the highest dose tolerated | Drug | Metoprolol |
Primary outcome
Platelet aggregation
Time frame: 30 days
Platelet aggregation induced by epinephrine is measured by Light Transmission Aggregometry (LTA)
2 secondary outcomes
30-days platelet aggregation
Time frame: 30 days
30-days clinical events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 24730697Bonten 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.
- Background: PubMed 25868659Ignjatovic 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Esposito, MD PhD principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carvedilol and Metoprolol in people with Acute Coronary Syndrome, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet aggregation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02809820, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.