Trial Outcomes & Findings for Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR) (NCT NCT01977456)

NCT ID: NCT01977456

Last Updated: 2016-01-21

Results Overview

Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

within 36 hours after stroke onset

Results posted on

2016-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	Eptifibatide All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
Overall Study STARTED	27
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Eptifibatide All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
Overall Study Death	5

Baseline Characteristics

Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eptifibatide n=27 Participants All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age, Continuous	70.4 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants
National Institutes of Health Stroke Scale Score (NIHSS)	12 score n=5 Participants

PRIMARY outcome

Timeframe: within 36 hours after stroke onset

Outcome measures

Outcome measures
Measure	Eptifibatide n=27 Participants All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
The Number of Patients Who Experience Symptomatic Intracerebral Hemorrhage (sICH).	1 participants

SECONDARY outcome

Timeframe: within 36 hours after stroke onset

Any ICH symptomatic (as defined above) or asymptomatic (that visualized on CT or MRI only)

Outcome measures

Outcome measures
Measure	Eptifibatide n=27 Participants All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
The Number of Patients Who Experience Any Intracerebral Hemorrhage (ICH).	2 participants

SECONDARY outcome

Timeframe: within 36 hours after stroke onset

Any parenchymal hemorrhage types PH-1 or PH-2 as visualized on CT

Outcome measures

Outcome measures
Measure	Eptifibatide n=27 Participants All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
The Number of Patients Who Develop Parenchymal Hemorrhage Types 1( PH-1) and 2 (PH-2).	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days from the date of stroke onset

Modified Rankin score (mRS) dichotomized to good outcome (mRS 0-1 or return to baseline), poor outcome (all others including death). Results reported are good outcome.

Outcome measures

Outcome measures
Measure	Eptifibatide n=27 Participants All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
The Number of Participants With Good Outcomes According to the Modified Rankin Score.	17 participants

Adverse Events

Eptifibatide

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Eptifibatide n=27 participants at risk All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
Blood and lymphatic system disorders Anaemias nonhaemolytic and marrow depression	3.7% 1/27 • Number of events 1 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Cardiac disorders Cardiac arrhythmias	3.7% 1/27 • Number of events 1 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Cardiac disorders Heart failures	3.7% 1/27 • Number of events 1 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Endocrine disorders Diabetic complications	3.7% 1/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Endocrine disorders Glucose metabolism disorders (incl diabetes mellitus)	3.7% 1/27 • Number of events 1 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
General disorders General system disorders NEC	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Metabolism and nutrition disorders Diabetic complications	3.7% 1/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Metabolism and nutrition disorders Glucose metabolism disorders (incl diabetes mellitus)	3.7% 1/27 • Number of events 1 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Nervous system disorders Neurological disorders NEC	3.7% 1/27 • Number of events 1 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge

Other adverse events

Other adverse events
Measure	Eptifibatide n=27 participants at risk All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
Blood and lymphatic system disorders Coagulopathies and bleeding diatheses (excl thrombocytopenic)	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Blood and lymphatic system disorders White blood cell disorders	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Cardiac disorders Cardiac arrhythmias	14.8% 4/27 • Number of events 4 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Gastrointestinal disorders Gastrointestinal motility and defaecation conditions	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Gastrointestinal disorders Gastrointestinal signs and symptoms	11.1% 3/27 • Number of events 3 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Infections and infestations Infections - pathogen unspecified	11.1% 3/27 • Number of events 3 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Metabolism and nutrition disorders Electrolyte and fluid balance conditions	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders NEC	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Nervous system disorders Neurological disorders NEC	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Psychiatric disorders Anxiety disorders and symptoms	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Renal and urinary disorders Genitourinary tract disorders NEC	11.1% 3/27 • Number of events 3 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Renal and urinary disorders Urinary tract signs and symptoms	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Skin and subcutaneous tissue disorders Epidermal and dermal conditions	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Skin and subcutaneous tissue disorders Skin vascular abnormalities	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Vascular disorders Decreased and nonspecific blood pressure disorders and shock	7.4% 2/27 • Number of events 2 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Vascular disorders Vascular haemorrhagic disorders	25.9% 7/27 • Number of events 8 • Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge

Additional Information

Dr. Opeolu Adeoye

University of Cincinnati

Phone: 513-558-3117

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place