Trial Outcomes & Findings for Role of Endothelin in Microvascular Dysfunction Following PCI for NSTEMI (NCT NCT00586820)

Results Overview

Coronary microvascular blood flow will be assessed following successful PCI by measuring APV in the culprit vessel using Doppler echocardiography.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

immediately following PCI procedure

Results posted on

2014-07-04

Participant Flow

Participant milestones

Participant milestones
Measure	BQ-123 The selective endothelin type A receptor antagonist (BQ-123) will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).	Placebo Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
Overall Study STARTED	12	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BQ-123 The selective endothelin type A receptor antagonist (BQ-123) will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).	Placebo Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
Overall Study Unsuccessful PCI	1	0

Baseline Characteristics

Role of Endothelin in Microvascular Dysfunction Following PCI for NSTEMI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BQ-123 n=11 Participants BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).	Placebo n=11 Participants Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.	Total n=22 Participants Total of all reporting groups
Age, Continuous	64.5 years STANDARD_DEVIATION 11.2 • n=5 Participants	64 years STANDARD_DEVIATION 12.5 • n=7 Participants	64.27 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: immediately following PCI procedure

Population: One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.

Coronary microvascular blood flow will be assessed following successful PCI by measuring APV in the culprit vessel using Doppler echocardiography.

Outcome measures

Outcome measures
Measure	BQ-123 n=11 Participants BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).	Placebo n=11 Participants Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
Average Peak Velocity (APV) Immediately Following Percutaneous Coronary Intervention (PCI)	30 cm/s Interval 20.0 to 37.0	19 cm/s Interval 9.0 to 26.0

SECONDARY outcome

Timeframe: immediately pre-PCI, 8 hours post-PCI, 16 hours post-PCI

Population: One subject on the BQ-123 arm was excluded from the analysis due to unsuccessful PCI.

CK-MB is a cardiac marker that can demonstrate the development of heart muscle necrosis resulting from an acute interruption of blood supply to a part of the heart. CK-MB is measured by a blood test.

Outcome measures

Outcome measures
Measure	BQ-123 n=11 Participants BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).	Placebo n=11 Participants Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
Percent Change in Creatinine Kinase Isoenzyme Muscle/Brain Type (CK-MB) From Immediately Pre-PCI to 8 and 16 Hours Post-PCI % Change immediate pre-PCI, 8 hr post-PCI	-17 percent change Interval -26.0 to -10.0	26 percent change Interval -15.0 to 134.0
Percent Change in Creatinine Kinase Isoenzyme Muscle/Brain Type (CK-MB) From Immediately Pre-PCI to 8 and 16 Hours Post-PCI % Change immediate pre-PCI, 16 hr post-PCI	-17 percent change Interval -38.0 to 14.0	107 percent change Interval 2.0 to 446.0

Adverse Events

BQ-123

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Amir Lerman

Mayo Clinic

Phone: 507-255-6670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place