Trial Outcomes & Findings for Enoxaparin and/or Minocycline in Acute Stroke (NCT NCT00836355)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Within approximately 7 days of stroke onset

Results posted on

2016-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Minocycline Minocycline 200 mg orally once daily for 5 days Minocycline: 200 mg orally once daily for 5 days	Control
Overall Study STARTED	4	2
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enoxaparin and/or Minocycline in Acute Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enoxaparin Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later	Minocycline n=4 Participants Minocycline 200 mg orally once daily for 5 days Minocycline: 200 mg orally once daily for 5 days	Enoxaparin and Minocycline Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later Minocycline: 200 mg orally once daily for 5 days	Control n=2 Participants	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=4 Participants	—	0 participants n=483 Participants	0 participants n=36 Participants
Age, Categorical Between 18 and 65 years	—	4 participants n=4 Participants	—	1 participants n=483 Participants	5 participants n=36 Participants
Age, Categorical >=65 years	—	0 participants n=4 Participants	—	1 participants n=483 Participants	1 participants n=36 Participants
Gender Female	—	1 participants n=4 Participants	—	1 participants n=483 Participants	2 participants n=36 Participants
Gender Male	—	3 participants n=4 Participants	—	1 participants n=483 Participants	4 participants n=36 Participants

PRIMARY outcome

Timeframe: Within approximately 7 days of stroke onset

Population: Although all participants completed the study, none of them had the necessary MRIs performed to gather outcome measure data. The study was closed once it was determined that logistically, it was not possible to complete the study at that point in time.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and after approximately one week

Population: This trial was terminated early because of logistical challenges in data collection. No outcome measures data was able to be collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, and approximately one week and 3 months later

Population: This trial was terminated early because of logistical challenges in data collection. No outcome measures data was able to be collected.

Outcome measures

Outcome data not reported

Adverse Events

Enoxaparin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Minocycline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enoxaparin and Minocycline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Saran Jonas

New York University Langone Medical Center

Phone: 212 263 7591

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place