Trial Outcomes & Findings for A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks (NCT NCT00604695)

NCT ID: NCT00604695

Last Updated: 2012-09-07

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention

Results posted on

2012-09-07

Participant Flow

The study randomized 40 primary percutaneous coronary intervention (PPCI) patients from 6 hospitals in the United States. The patients were given either a volume matched bolus of intracoronary (IC) tenecteplase (TNK) (4 mg; n=20) or IC saline placebo (4 mg; n=16) before and following PPCI. 4 subjects were randomized but did not receive 1st bolus.

Participant milestones

Participant milestones
Measure	Active Treatment Two (4mg) doses of tenecteplase	Placebo Control Two (4mL) doses of sterile saline
Overall Study STARTED	20	20
Overall Study COMPLETED	20	16
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Treatment Two (4mg) doses of tenecteplase	Placebo Control Two (4mL) doses of sterile saline
Overall Study Did not receive first bolus.	0	4

Baseline Characteristics

A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment n=20 Participants Two (4mg) doses of tenecteplase	Placebo Control n=20 Participants Two (4mL) doses of sterile saline	Total n=40 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	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age Continuous	55.2 years STANDARD_DEVIATION 7.6 • n=5 Participants	55.6 years STANDARD_DEVIATION 8.9 • n=7 Participants	55.4 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention

Population: Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1. Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1.

Outcome measures

Outcome measures
Measure	Active Treatment n=16 Participants Two (4mg) doses of tenecteplase	Placebo Control n=13 Participants Two (4mL) doses of sterile saline
Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention	100 Percent diameter stenosis Interval 83.0 to 100.0	100 Percent diameter stenosis Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention

Outcome measures

Outcome measures
Measure	Active Treatment n=16 Participants Two (4mg) doses of tenecteplase	Placebo Control n=13 Participants Two (4mL) doses of sterile saline
Number of Patients With Decrease in Thrombus Grade in the Culprit Artery Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention	7 participants	2 participants

SECONDARY outcome

Timeframe: Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug

Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the territory of the culprit artery

Outcome measures

Outcome measures
Measure	Active Treatment n=16 Participants Two (4mg) doses of tenecteplase	Placebo Control n=13 Participants Two (4mL) doses of sterile saline
Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the Territory of the Culprit Artery Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug	8 participants	8 participants

SECONDARY outcome

Timeframe: Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug

Population: Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients

Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) in the culprit artery

Outcome measures

Outcome measures
Measure	Active Treatment n=12 Participants Two (4mg) doses of tenecteplase	Placebo Control n=10 Participants Two (4mL) doses of sterile saline
Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC)	26 Corrected TIMI Frame Count (cTFC) Interval 21.0 to 33.0	14 Corrected TIMI Frame Count (cTFC) Interval 10.0 to 24.0

SECONDARY outcome

Timeframe: Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug

Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of less than 14

Outcome measures

Outcome measures
Measure	Active Treatment n=12 Participants Two (4mg) doses of tenecteplase	Placebo Control n=10 Participants Two (4mL) doses of sterile saline
Number of Patients With Hyperemic Flow in the Culprit Artery. That is Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Less Than 14	1 participants	5 participants

SECONDARY outcome

Timeframe: Through 30days following PPCI

Population: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)

Outcome measures

Outcome measures
Measure	Active Treatment n=20 Participants Two (4mg) doses of tenecteplase	Placebo Control n=16 Participants Two (4mL) doses of sterile saline
Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding	1 participants	0 participants

SECONDARY outcome

Timeframe: Through 30days following primary percutaneous coronary intervention

Population: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)

Outcome measures

Outcome measures
Measure	Active Treatment n=20 Participants Two (4mg) doses of tenecteplase	Placebo Control n=16 Participants Two (4mL) doses of sterile saline
Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding	4 participants	2 participants

SECONDARY outcome

Timeframe: Through 30days following primary percutaneous coronary intervention

Population: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)

Outcome measures

Outcome measures
Measure	Active Treatment n=20 Participants Two (4mg) doses of tenecteplase	Placebo Control n=16 Participants Two (4mL) doses of sterile saline
Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias	1 participants	2 participants

SECONDARY outcome

Timeframe: Through 30days following primary percutaneous coronary intervention

Population: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)

Outcome measures

Outcome measures
Measure	Active Treatment n=20 Participants Two (4mg) doses of tenecteplase	Placebo Control n=16 Participants Two (4mL) doses of sterile saline
Safety Endpoint: Number of Deaths	1 participants	0 participants

Adverse Events

Active Treatment

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo Control

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Treatment n=20 participants at risk Two (4mg) doses of tenecteplase	Placebo Control n=16 participants at risk Two (4mL) doses of sterile saline
Gastrointestinal disorders Erosive Gastritis	5.0% 1/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	0.00% 0/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Cardiac disorders Dressler's syndrome	0.00% 0/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	6.2% 1/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
General disorders Death	5.0% 1/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	0.00% 0/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).

Other adverse events

Additional Information

C. Michael Gibson, MS, MD

Brigham & Women's Hospital

Phone: 617-632-7753

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal Investigator shall furnish Sponsor with copy of any proposed publication for review/comment prior to submission for publication, at least thirty (30) days prior to submission for manuscripts and at least fifteen (15) days prior to submission for abstracts. Institution agrees to delete information identified by Sponsor as Confidential Information prior to submission for publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Active Treatment n=20 participants at risk Two (4mg) doses of tenecteplase	Placebo Control n=16 participants at risk Two (4mL) doses of sterile saline
Blood and lymphatic system disorders Anemia	5.0% 1/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	0.00% 0/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Cardiac disorders Ventricular Tachycardia	5.0% 1/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	6.2% 1/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Gastrointestinal disorders Pancreatitis	5.0% 1/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	0.00% 0/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Injury, poisoning and procedural complications Incision site pain	5.0% 1/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	0.00% 0/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Infections and infestations Clostridium difficile infection	5.0% 1/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	0.00% 0/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Injury, poisoning and procedural complications Right hand and finger numbness	0.00% 0/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	6.2% 1/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Injury, poisoning and procedural complications Right groin cellulitis	0.00% 0/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	6.2% 1/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Infections and infestations Urinary tract infection	5.0% 1/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	0.00% 0/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	6.2% 1/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Immune system disorders Allergic reaction to Bactrim	0.00% 0/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	6.2% 1/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Immune system disorders Allergic reaction to Lisinopril	0.00% 0/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	6.2% 1/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Injury, poisoning and procedural complications Bleeding	25.0% 5/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	12.5% 2/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Cardiac disorders Hypotension	5.0% 1/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	0.00% 0/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Cardiac disorders Chest pain	5.0% 1/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	6.2% 1/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
General disorders Back pain	0.00% 0/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	6.2% 1/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Cardiac disorders High grade Atrio-Ventricular Block	5.0% 1/20 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).	6.2% 1/16 • 30-days following primary percutaneous coronary intervention Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).