Trial Outcomes & Findings for Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome (NCT NCT00514501)

NCT ID: NCT00514501

Last Updated: 2016-03-31

Results Overview

Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 510 participants
• Primary outcome timeframe: Day 30
• Results posted on: 2016-03-31

Participant Flow

Participant milestones

Measure	Iodofiltic Acid I 123 A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
Overall Study STARTED	510
Overall Study COMPLETED	507
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome

Baseline characteristics by cohort

Measure	Iodofiltic Acid I 123 n=507 Participants A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
Age, Continuous	59.2 years n=5 Participants
Sex: Female, Male Female	232 Participants n=5 Participants
Sex: Female, Male Male	275 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.

Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).

Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.

Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.

Outcome measures

Measure	Iodofiltic Acid I 123 n=342 Participants A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1) Sensitivity	75.2 % (n/N) Interval 66.8 to 83.6
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1) Specificity	67.7 % (n/N) Interval 61.4 to 74.0

PRIMARY outcome

Timeframe: Day 30

Population: The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.

Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).

Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.

Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.

Outcome measures

Measure	Iodofiltic Acid I 123 n=342 Participants A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2) Specificity	59.8 % (n/N) Interval 53.3 to 66.4
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2) Sensitivity	75.2 % (n/N) Interval 66.8 to 83.6

PRIMARY outcome

Timeframe: Day 30

Population: The study enrolled a total of 510 subjects; 507 of these subjects received iodofiltic acid I 123, and 506 had iodofiltic acid I 123 SPECT images available. Of the 507 subjects who were dosed, 342 were eligible for efficacy evaluation.

Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC).

Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.

Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers.

Outcome measures

Measure	Iodofiltic Acid I 123 n=342 Participants A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3) Sensitivity	74.3 % (n/N) Interval 65.8 to 82.8
Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3) Specificity	71.6 % (n/N) Interval 65.6 to 77.7

Adverse Events

Iodofiltic Acid I 123

Serious events: 28 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Iodofiltic Acid I 123 n=507 participants at risk A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
Cardiac disorders Cardiac failure, acute	0.39% 2/507 • Number of events 3
Cardiac disorders Cardiac arrest	0.39% 2/507 • Number of events 2
Cardiac disorders Ventricular fibrillation	0.20% 1/507 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.20% 1/507 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	0.39% 2/507 • Number of events 2
Nervous system disorders Mental status changes	0.20% 1/507 • Number of events 1
Cardiac disorders Chest pain	0.79% 4/507 • Number of events 5
Cardiac disorders Myocardial infarction	0.59% 3/507 • Number of events 3
Renal and urinary disorders Renal failure	0.20% 1/507 • Number of events 1
Injury, poisoning and procedural complications Arterial injury	0.20% 1/507 • Number of events 1
Cardiac disorders Unstable angina	0.59% 3/507 • Number of events 3
Cardiac disorders Aortic dissection	0.39% 2/507 • Number of events 2
Vascular disorders Hematoma	0.39% 2/507 • Number of events 2
Respiratory, thoracic and mediastinal disorders Pneumonia	0.39% 2/507 • Number of events 2
Gastrointestinal disorders Gastroesophageal reflux disease	0.20% 1/507 • Number of events 1

Other adverse events

Measure	Iodofiltic Acid I 123 n=507 participants at risk A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
Nervous system disorders Dysgeusia	2.4% 12/507 • Number of events 12
Nervous system disorders Headache	3.9% 20/507 • Number of events 20

Additional Information

Senior Director of Clinical Communications

Progenics Pharmaceuticals, Inc.

Phone: 914 784-1825

Email: vdipippo@progenics.com

Results disclosure agreements

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

Restriction type: LTE60