Trial Outcomes & Findings for Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions (NCT NCT01241903)

NCT ID: NCT01241903

Last Updated: 2017-03-28

Results Overview

measured by flow cytometry

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 54 participants
• Primary outcome timeframe: within first 24 hours
• Results posted on: 2017-03-28

Participant Flow

Participant milestones

Measure	Placebo Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.	Rosuvastatin Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
Overall Study STARTED	27	27
Overall Study COMPLETED	26	27
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions

Baseline characteristics by cohort

Measure	Placebo n=26 Participants Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.	Rosuvastatin n=27 Participants Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.	Total n=53 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 10.7 • n=5 Participants	57.2 years STANDARD_DEVIATION 10.4 • n=7 Participants	56.0 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: within first 24 hours

measured by flow cytometry

Outcome measures

Measure	Placebo n=24 Participants Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.	Rosuvastatin n=23 Participants Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
Platelet - Leukocyte Aggregates Baseline	29.2 % leukocytes with platelets attached Standard Error 3.8	39.8 % leukocytes with platelets attached Standard Error 4.9
Platelet - Leukocyte Aggregates 8 Hour	26.2 % leukocytes with platelets attached Standard Error 4.2	21.1 % leukocytes with platelets attached Standard Error 3.2
Platelet - Leukocyte Aggregates 24 Hour	24.4 % leukocytes with platelets attached Standard Error 4.2	21.3 % leukocytes with platelets attached Standard Error 2.8

SECONDARY outcome

Timeframe: up to 30 days

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Rosuvastatin

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=26 participants at risk Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.	Rosuvastatin n=27 participants at risk Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/26	3.7% 1/27 • Number of events 1
Cardiac disorders Death	3.8% 1/26 • Number of events 1	0.00% 0/27
Blood and lymphatic system disorders Stroke	3.8% 1/26 • Number of events 1	0.00% 0/27

Other adverse events

Measure	Placebo n=26 participants at risk Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.	Rosuvastatin n=27 participants at risk Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
Skin and subcutaneous tissue disorders Rash	3.8% 1/26 • Number of events 1	0.00% 0/27
Social circumstances Alcohol Toxicity	0.00% 0/26	3.7% 1/27 • Number of events 1
Social circumstances Nightmare	3.8% 1/26 • Number of events 1	0.00% 0/27

Additional Information

Dr. Susan S. Smyth

University of Kentucky

Phone: (859) 323-2274

Email: ssmyt2@uky.edu

Results disclosure agreements

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