Trial Outcomes & Findings for Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction (NCT NCT00367991)

NCT ID: NCT00367991

Last Updated: 2018-01-12

Results Overview

An integrated measure of in vivo platelet function and tissue hemostasis.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 44 participants
• Primary outcome timeframe: Change from Day 3 to Day 10
• Results posted on: 2018-01-12

Participant Flow

Participant milestones

Measure	rHuEPO recombinant human erythropoietin 200 U/kg IV daily for 3 days	Placebo Normal saline volume to match active treatment IV daily for 3 days
Overall Study STARTED	29	15
Overall Study COMPLETED	27	13
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	rHuEPO recombinant human erythropoietin 200 U/kg IV daily for 3 days	Placebo Normal saline volume to match active treatment IV daily for 3 days
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	1	1

Baseline Characteristics

Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction

Baseline characteristics by cohort

Measure	rHuEPO n=29 Participants recombinant human erythropoietin 200 U/kg IV daily for 3 days	Placebo n=15 Participants Normal saline volume to match active treatment IV daily for 3 days	Total n=44 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	22 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 12 • n=5 Participants	53 years STANDARD_DEVIATION 9 • n=7 Participants	56 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	15 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Day 3 to Day 10

Population: ITT

An integrated measure of in vivo platelet function and tissue hemostasis.

Outcome measures

Measure	Placebo n=15 Participants normal saline	rHuEPO n=29 Participants recombinant human erythropoietin
Bleeding Time	1020 seconds Interval 960.0 to 1110.0	1020 seconds Interval 960.0 to 1110.0

PRIMARY outcome

Timeframe: Change from Day 3 to Day 10

Population: ITT

Outcome measures

Measure	Placebo n=15 Participants normal saline	rHuEPO n=29 Participants recombinant human erythropoietin
Platelet Function Assay Closure Time	251 seconds Interval 185.0 to 301.0	281 seconds Interval 173.0 to 301.0

SECONDARY outcome

Timeframe: Day 1 and Day 10

Population: These data were not collected due to lack of funds.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: ITT

Myocyte Damage is represented by Creatine phosphokinase (CPK). CPK is measured in U/L, as scalar measure of the enzyme activity. CPK was measured for clinical indications laboratory.

Outcome measures

Measure	Placebo n=15 Participants normal saline	rHuEPO n=29 Participants recombinant human erythropoietin
Serum Markers of Myocyte Damage	817 U/L Interval 114.0 to 2040.0	652 U/L Interval 379.0 to 868.0

SECONDARY outcome

Timeframe: Day 3 and Day 10

Population: Endothelial progenitor cells could not be isolated and are therefore not reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 and Day 10

Population: ITT

Apoptosis is represented by Fas ligand (FasL or CD95L). FasL (CD95L) is measured in pg/mL.

Outcome measures

Measure	Placebo n=15 Participants normal saline	rHuEPO n=29 Participants recombinant human erythropoietin
Serum Markers of Apoptosis Day 1	45 pg/mL Standard Deviation 12	56 pg/mL Standard Deviation 19
Serum Markers of Apoptosis Day 10	60 pg/mL Standard Deviation 18	63 pg/mL Standard Deviation 22

Adverse Events

rHuEPO

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	rHuEPO n=29 participants at risk recombinant human erythropoietin 200 U/kg IV daily for 3 days	Placebo n=15 participants at risk Normal saline volume to match active treatment IV daily for 3 days
Cardiac disorders hospitalization	3.4% 1/29 • Number of events 1	6.7% 1/15 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Stuart Katz, MD

New York University School of Medicine

Phone: 212-263-3946

Email: stuart.katz@nyumc.org

Results disclosure agreements

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