Trial Outcomes & Findings for Comparison of Diltiazem and Metoprolol in the Management of Acute Atrial Fibrillation or Atrial Flutter (NCT NCT01914926)

NCT ID: NCT01914926

Last Updated: 2014-05-15

Results Overview

Percent of patient who reached a HR\<100bpm within 30 minutes from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 54 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2014-05-15

Participant Flow

Recruitment of patients was from June 2009 to November 2010

No significant events

Participant milestones

Measure	Metoprolol Study Group Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)	Diltiazem Study Group Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
Overall Study STARTED	29	25
Overall Study COMPLETED	28	24
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Metoprolol Study Group Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)	Diltiazem Study Group Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
Overall Study Adverse Event	1	0
Overall Study uncooperative, agitated and removed	0	1

Baseline Characteristics

Comparison of Diltiazem and Metoprolol in the Management of Acute Atrial Fibrillation or Atrial Flutter

Baseline characteristics by cohort

Measure	Metoprolol Study Group n=29 Participants Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)	Diltiazem Study Group n=25 Participants Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Age, Continuous	68.95 years STANDARD_DEVIATION 14.94 • n=5 Participants	65.85 years STANDARD_DEVIATION 13.22 • n=7 Participants	67.52 years STANDARD_DEVIATION 14.12 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	25 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

Percent of patient who reached a HR<100bpm within 30 minutes from baseline.

Outcome measures

Measure	Metoprolol Study Group n=28 Participants Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)	Diltiazem Study Group n=24 Participants Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
Percent of Patients Reaching Target HR<100bpm Within 30 Minutes	46.4 percentage of participants	95.8 percentage of participants

Adverse Events

Metoprolol Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diltiazem Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christian Fromm, MD; Director of Research

Maimonides Medical Center

Phone: 718-283-6391

Email: cfromm@maimonidesmed.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place