NCT04221919

Brief Summary

Carvedilol, target dose: 50 mg daily; Bisoprolol, target dose: 10 mg daily; Metoprolol tartrate, target dose: 150 mg daily; Metroprolol succinate, target dose: 200 mg daily

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 5, 2020

Last Update Submit

January 7, 2020

Conditions

Primary PCI

Outcome Measures

Primary Outcomes (2)

  • Change in LVEDV from baseline

    The primary outcome of this study will be the change from baseline in left ventricular end diastolic volume (LVEDV) post-PCI.

    1 to 5 years

  • Major adverse cardiovascular events (MACE)

    1 to 5 years

Study Arms (4)

Carvedilol

EXPERIMENTAL
Drug: β -Blockers

Bisoprolol

EXPERIMENTAL
Drug: β -Blockers

Metoprolol tartrate

EXPERIMENTAL
Drug: β -Blockers

Metoprolol succinate

EXPERIMENTAL
Drug: β -Blockers

Interventions

β -BlockersDRUG

Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate

BisoprololCarvedilolMetoprolol succinateMetoprolol tartrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes;
  • Age ≥18 years;
  • Informed consent from patient or next of kin.

You may not qualify if:

  • Nonischaemic Cardiomyopathy;
  • Cardiac surgery planed in the 6 months;
  • Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation);
  • Renal or hepatic failure;
  • Malignancy, HIV, or central nervous system disorder;
  • Cardiopulmonary resuscitation \>15 min and compromised level of consciousness;
  • Cardiogenic shock;
  • Current participation in any research study involving investigational drugs or devices;
  • No written consensus;
  • Previous myocardial infarction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 9, 2020

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2025

Last Updated

January 9, 2020

Record last verified: 2020-01