Phase 2 N=56 Randomized Double-blind Prevention

Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting

Coronary Artery Bypass Grafting · Cardiopulmonary Bypass · Reperfusion Injury

Bottom Line

View on ClinicalTrials.gov: NCT00246740 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcome: Primary: Left Ventricular Stroke Work Index (LVSWI) — 42; 43; 29; 28 g*m/m2

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Periostat (Drug); Placebo Oral Tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alberta
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Left Ventricular Stroke Work Index (LVSWI)	42; 43; 29; 28; 30; 29	—
SECONDARY Cardiac Matrix Metalloproteinase-9 Activity in Right Atrial Biopsies at 10 Minutes Reperfusion	.75; 1.56; .44; 1.63	—
SECONDARY Cardiac Matrix Metalloproteinase-2 Activity in Right Atrial Biopsies at 10 Minutes Reperfusion	.36; .24; .42; .25	—
SECONDARY Venous Plasma Cardiac Matrix Metalloproteinase-9 Activity Before and After Reperfusion	.07; .11; .06; .12; 1.22; 1.37	—
SECONDARY Venous Plasma Cardiac Matrix Metalloproteinase-2 Activity Before and After Reperfusion	.99; 1.06; .93; .96; 1.01; 1.05	—
SECONDARY Venous Plasma Concentration of Troponin-I	1.23; 1.07; 1.39; 1.78	—
SECONDARY Cleaved TroponinI/GAPDH Ratios in Right Atrial Biopsy	1.1318; 2.3454; 1.5195; 2.1893	—
SECONDARY Venous Plasma Concentration of C-reactive Protein	5.7; 10; 5.7; 9.9; 4; 7.5	—
SECONDARY Venous Plasma Concentration of IL-6	5.7; 1.9; 5.6; 2.8; 15.4; 7.3	—

Summary

The purpose of this study is to determine whether doxycycline (Periostat) at a sub-antimicrobial dose will decrease reperfusion injury after coronary artery bypass grafting (CABG) surgery with cardiopulmonary bypass (CPB).

Eligibility Criteria

Inclusion Criteria

Written informed consent
Aged 18 through 80 years, inclusive
Scheduled for primary CABG surgery with CPB

Exclusion Criteria

Females of childbearing potential
Emergency CABG
Previous sternotomy
Planned simultaneous surgery (i.e. valve repair or carotid endarterectomy)
Myocardial infarction within 48 hours
Pre-operative atrial fibrillation
Pre-operative ventricular pacing or left bundle branch block (LBBB)
Known hypersensitivity to tetracycline class antibiotics
Renal failure requiring dialysis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00246740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.