Trial Outcomes & Findings for Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting (NCT NCT00246740)
NCT ID: NCT00246740
Last Updated: 2017-12-15
Results Overview
Measure of global left ventricular function. The formula used for calculation is: LVSWI= SI x MAP x 0.0144 LVSWI = Left Ventricular Stroke Work Index (g\*m/m2) SI = Stroke Index (mL/beat/m2) MAP = Mean Arterial Pressure (mmHg) 0.0144 is a conversion term to equalize units.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Before surgery up to 24h of reperfusion
Results posted on
2017-12-15
Participant Flow
Participant milestones
| Measure |
Placebo Oral Tablet
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
|---|---|---|
|
Initial Enrollment
STARTED
|
28
|
28
|
|
Initial Enrollment
COMPLETED
|
22
|
20
|
|
Initial Enrollment
NOT COMPLETED
|
6
|
8
|
|
Experimental Phase
STARTED
|
22
|
20
|
|
Experimental Phase
COMPLETED
|
22
|
20
|
|
Experimental Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Oral Tablet
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
|---|---|---|
|
Initial Enrollment
Death
|
1
|
0
|
|
Initial Enrollment
Additional surgery scheduled
|
0
|
2
|
|
Initial Enrollment
Surgery schedule change
|
4
|
4
|
|
Initial Enrollment
Other
|
1
|
2
|
Baseline Characteristics
Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting
Baseline characteristics by cohort
| Measure |
Placebo Oral Tablet
n=22 Participants
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
n=20 Participants
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 2 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before surgery up to 24h of reperfusionMeasure of global left ventricular function. The formula used for calculation is: LVSWI= SI x MAP x 0.0144 LVSWI = Left Ventricular Stroke Work Index (g\*m/m2) SI = Stroke Index (mL/beat/m2) MAP = Mean Arterial Pressure (mmHg) 0.0144 is a conversion term to equalize units.
Outcome measures
| Measure |
Placebo Oral Tablet
n=22 Participants
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
n=20 Participants
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
|---|---|---|
|
Left Ventricular Stroke Work Index (LVSWI)
Before surgery
|
42 g*m/m2
Standard Error 2.6
|
43 g*m/m2
Standard Error 2.5
|
|
Left Ventricular Stroke Work Index (LVSWI)
Post surgery
|
29 g*m/m2
Standard Error 1.7
|
28 g*m/m2
Standard Error 1.7
|
|
Left Ventricular Stroke Work Index (LVSWI)
1h reperfusion
|
30 g*m/m2
Standard Error 1.8
|
29 g*m/m2
Standard Error 1.9
|
|
Left Ventricular Stroke Work Index (LVSWI)
3h reperfusion
|
31 g*m/m2
Standard Error 1.9
|
29 g*m/m2
Standard Error 2
|
|
Left Ventricular Stroke Work Index (LVSWI)
6h reperfusion
|
28 g*m/m2
Standard Error 1.4
|
25 g*m/m2
Standard Error 1.4
|
|
Left Ventricular Stroke Work Index (LVSWI)
12h reperfusion
|
30 g*m/m2
Standard Error 1.6
|
30 g*m/m2
Standard Error 1.7
|
|
Left Ventricular Stroke Work Index (LVSWI)
24h reperfusion
|
32 g*m/m2
Standard Error 1.8
|
33 g*m/m2
Standard Error 1.9
|
SECONDARY outcome
Timeframe: Before surgery and 10 minutes reperfusion after surgeryBiochemical activity of MMP-9 activity in right atrial biopsies, measured at 10 minutes of reperfusion after surgery. To determine MMP-9 activity, 20 μg of total protein from both myocardial extracts and plasma were analyzed by gelatin zymography. For detailed methodology consult Cheung PY, Sawicki G, Wozniak M, et al: Matrix metalloproteinase-2 contributes to ischemia-reperfusion injury in the heart. Circulation 2000; 101:1833-1839
Outcome measures
| Measure |
Placebo Oral Tablet
n=22 Participants
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
n=20 Participants
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
|---|---|---|
|
Cardiac Matrix Metalloproteinase-9 Activity in Right Atrial Biopsies at 10 Minutes Reperfusion
Before surgery
|
.75 Arbitrary units
Standard Error .25
|
1.56 Arbitrary units
Standard Error .26
|
|
Cardiac Matrix Metalloproteinase-9 Activity in Right Atrial Biopsies at 10 Minutes Reperfusion
10 min reperfusion
|
.44 Arbitrary units
Standard Error .28
|
1.63 Arbitrary units
Standard Error .29
|
SECONDARY outcome
Timeframe: Before surgery and 10 minutes reperfusion after surgeryBiochemical activity of MMP-2 activity in right atrial biopsies, measured at 10 minutes of reperfusion after surgery.
Outcome measures
| Measure |
Placebo Oral Tablet
n=22 Participants
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
n=20 Participants
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
|---|---|---|
|
Cardiac Matrix Metalloproteinase-2 Activity in Right Atrial Biopsies at 10 Minutes Reperfusion
Before surgery
|
.36 Arbitrary units
Standard Error .04
|
.24 Arbitrary units
Standard Error .04
|
|
Cardiac Matrix Metalloproteinase-2 Activity in Right Atrial Biopsies at 10 Minutes Reperfusion
10 min reperfusion
|
.42 Arbitrary units
Standard Error .04
|
.25 Arbitrary units
Standard Error .04
|
SECONDARY outcome
Timeframe: Before surgery and up to 72 h reperfusion after surgeryBiochemical activity of MMP-9 activity in venous plasma, measured before surgery and up to 72h of reperfusion after surgery.
Outcome measures
| Measure |
Placebo Oral Tablet
n=22 Participants
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
n=20 Participants
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
|---|---|---|
|
Venous Plasma Cardiac Matrix Metalloproteinase-9 Activity Before and After Reperfusion
Before anesthesia
|
.07 Arbitrary units
Standard Error .04
|
.11 Arbitrary units
Standard Error .04
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-9 Activity Before and After Reperfusion
After anesthesia
|
.06 Arbitrary units
Standard Error .04
|
.12 Arbitrary units
Standard Error .04
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-9 Activity Before and After Reperfusion
10 min reperfusion
|
1.22 Arbitrary units
Standard Error .08
|
1.37 Arbitrary units
Standard Error .08
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-9 Activity Before and After Reperfusion
20 min reperfusion
|
1.14 Arbitrary units
Standard Error .09
|
1.3 Arbitrary units
Standard Error .09
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-9 Activity Before and After Reperfusion
3 h reperfusion
|
.52 Arbitrary units
Standard Error .08
|
.53 Arbitrary units
Standard Error .08
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-9 Activity Before and After Reperfusion
6 h reperfusion
|
.21 Arbitrary units
Standard Error .04
|
.22 Arbitrary units
Standard Error .04
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-9 Activity Before and After Reperfusion
24 h reperfusion
|
.05 Arbitrary units
Standard Error .03
|
.09 Arbitrary units
Standard Error .01
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-9 Activity Before and After Reperfusion
72 h reperfusion
|
.03 Arbitrary units
Standard Error .01
|
.03 Arbitrary units
Standard Error .01
|
SECONDARY outcome
Timeframe: Before surgery and up to 72 h reperfusion after surgeryBiochemical activity of MMP-2 activity in venous plasma, measured before surgery and up to 72h of reperfusion after surgery.
Outcome measures
| Measure |
Placebo Oral Tablet
n=22 Participants
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
n=20 Participants
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
|---|---|---|
|
Venous Plasma Cardiac Matrix Metalloproteinase-2 Activity Before and After Reperfusion
3 h reperfusion
|
.99 Arbitrary units
Standard Error .05
|
1.06 Arbitrary units
Standard Error .05
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-2 Activity Before and After Reperfusion
Before anesthesia
|
.99 Arbitrary units
Standard Error .05
|
1.06 Arbitrary units
Standard Error .05
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-2 Activity Before and After Reperfusion
After anesthesia
|
.93 Arbitrary units
Standard Error .04
|
.96 Arbitrary units
Standard Error .04
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-2 Activity Before and After Reperfusion
10 min reperfusion
|
1.01 Arbitrary units
Standard Error .06
|
1.05 Arbitrary units
Standard Error .06
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-2 Activity Before and After Reperfusion
20 min reperfusion
|
.87 Arbitrary units
Standard Error .04
|
1 Arbitrary units
Standard Error .04
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-2 Activity Before and After Reperfusion
6 h reperfusion
|
.92 Arbitrary units
Standard Error .07
|
1.07 Arbitrary units
Standard Error .07
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-2 Activity Before and After Reperfusion
24 h reperfusion
|
.78 Arbitrary units
Standard Error .05
|
.9 Arbitrary units
Standard Error .05
|
|
Venous Plasma Cardiac Matrix Metalloproteinase-2 Activity Before and After Reperfusion
72 h reperfusion
|
.78 Arbitrary units
Standard Error .04
|
.9 Arbitrary units
Standard Error .04
|
SECONDARY outcome
Timeframe: Before surgery and 10 minutes reperfusion after surgeryMeasurement of levels of TnI (troponin-I), a marker of cardiac cell damage
Outcome measures
| Measure |
Placebo Oral Tablet
n=22 Participants
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
n=20 Participants
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
|---|---|---|
|
Venous Plasma Concentration of Troponin-I
Before surgery
|
1.23 pg/ml
Standard Error .33
|
1.07 pg/ml
Standard Error .34
|
|
Venous Plasma Concentration of Troponin-I
Post surgery
|
1.39 pg/ml
Standard Error .46
|
1.78 pg/ml
Standard Error .47
|
SECONDARY outcome
Timeframe: Before surgery and 10 minutes reperfusion after surgeryMeasurement of the ratios of cleaved TnI (troponin-I) versus GAPDH in biopsies collected from right atria. Measure is the ratio TnI/GAPDH
Outcome measures
| Measure |
Placebo Oral Tablet
n=22 Participants
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
n=20 Participants
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
|---|---|---|
|
Cleaved TroponinI/GAPDH Ratios in Right Atrial Biopsy
Before surgery
|
1.1318 Arbitrary units-Cleaved TnI/GAPDH
Standard Error .3852
|
2.3454 Arbitrary units-Cleaved TnI/GAPDH
Standard Error .3978
|
|
Cleaved TroponinI/GAPDH Ratios in Right Atrial Biopsy
Post surgery
|
1.5195 Arbitrary units-Cleaved TnI/GAPDH
Standard Error .3745
|
2.1893 Arbitrary units-Cleaved TnI/GAPDH
Standard Error .3868
|
SECONDARY outcome
Timeframe: Before surgery and up to 72 h reperfusion after surgeryMeasurement of inflammation marker C-reactive protein in plasma
Outcome measures
| Measure |
Placebo Oral Tablet
n=22 Participants
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
n=20 Participants
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
|---|---|---|
|
Venous Plasma Concentration of C-reactive Protein
Before anesthesia
|
5.7 ng/ml
Standard Error 2
|
10 ng/ml
Standard Error 2
|
|
Venous Plasma Concentration of C-reactive Protein
After anesthesia
|
5.7 ng/ml
Standard Error 1.8
|
9.9 ng/ml
Standard Error 2
|
|
Venous Plasma Concentration of C-reactive Protein
10 min reperfusion
|
4 ng/ml
Standard Error 1.3
|
7.5 ng/ml
Standard Error 1.5
|
|
Venous Plasma Concentration of C-reactive Protein
20 min reperfusion
|
4 ng/ml
Standard Error 1.5
|
7.2 ng/ml
Standard Error 1.3
|
|
Venous Plasma Concentration of C-reactive Protein
3 h reperfusion
|
5.2 ng/ml
Standard Error 1.7
|
9.4 ng/ml
Standard Error 1.8
|
|
Venous Plasma Concentration of C-reactive Protein
6 h reperfusion
|
12.9 ng/ml
Standard Error 2
|
16.3 ng/ml
Standard Error 2.1
|
|
Venous Plasma Concentration of C-reactive Protein
24 h reperfusion
|
51 ng/ml
Standard Error 1.9
|
48.8 ng/ml
Standard Error 1.9
|
|
Venous Plasma Concentration of C-reactive Protein
72 h reperfusion
|
51.1 ng/ml
Standard Error 1.2
|
51.2 ng/ml
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Before surgery and up to 72 h reperfusion after surgeryMeasurement of inflammation marker interleukin-6 in plasma
Outcome measures
| Measure |
Placebo Oral Tablet
n=22 Participants
Patients received oral administration of matching placebo pills, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Placebo Oral Tablet: In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
Periostat
n=20 Participants
Patients received oral administration of 20 mg of doxycycline, twice a day at least 2 days prior to surgery, on the day of surgery, and for the first 3 postoperative days (via a nasogastric tube or orally when patients tolerated it).
Periostat: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
|
|---|---|---|
|
Venous Plasma Concentration of IL-6
Before anesthesia
|
5.7 pg/ml
Standard Error 2
|
1.9 pg/ml
Standard Error 2
|
|
Venous Plasma Concentration of IL-6
After anesthesia
|
5.6 pg/ml
Standard Error 1.9
|
2.8 pg/ml
Standard Error 1.9
|
|
Venous Plasma Concentration of IL-6
10 min reperfusion
|
15.4 pg/ml
Standard Error 2.7
|
7.3 pg/ml
Standard Error 2.7
|
|
Venous Plasma Concentration of IL-6
20 min reperfusion
|
24.4 pg/ml
Standard Error 3.3
|
15.1 pg/ml
Standard Error 3.4
|
|
Venous Plasma Concentration of IL-6
3 h reperfusion
|
72.9 pg/ml
Standard Error 6.6
|
76.1 pg/ml
Standard Error 6.7
|
|
Venous Plasma Concentration of IL-6
6 h reperfusion
|
75.6 pg/ml
Standard Error 5.9
|
83.4 pg/ml
Standard Error 6
|
|
Venous Plasma Concentration of IL-6
24 h reperfusion
|
66.4 pg/ml
Standard Error 6.4
|
71.8 pg/ml
Standard Error 6.5
|
|
Venous Plasma Concentration of IL-6
72 h reperfusion
|
39 pg/ml
Standard Error 5.7
|
28.1 pg/ml
Standard Error 5.8
|
Adverse Events
Placebo Oral Tablet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Periostat
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 Richard Schulz
Departments of Pediatrics and Pharmacology, University of Alberta
Phone: 780-492-6581
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place