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Effect of Low-dose Intracoronary Reteplase on Myocardial Infarct Size During Primary Percutaneous Coronary Intervention (RECOVERII)

Primary Purpose

Acute ST-segment Elevation Myocardial Infarction

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Normal Saline
Reteplase Injection 9mg
Reteplase Injection 18mg
Sponsored by
Ge Junbo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute ST-segment Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Acute STEMI with persistent ST-segment elevation or recent left bundle-branch block with a symptom onset to reperfusion time of 12 hours or less.
  2. Angiographic criteria included a proximal-mid coronary artery occlusion (TIMI coronary flow grade 0 or 1) or, impaired coronary flow (TIMI flow grade 2, slow but complete filling) in the presence of definite angiographic evidence of large thrombus (TIMI grade ≥2) in left anterior descending (LAD) coronary artery.

Exclusion Criteria:

  1. Rescue PCI after thrombolytic therapy.
  2. Need for emergency coronary artery bypass grafting.
  3. Presence of cardiogenic shock.
  4. Life expectancy of < 6 months.
  5. Inability to provide informed consent.
  6. Contraindications for the use of thrombolysis, including active internal bleeding, history of intracranial haemorrhage or ischaemic stroke within 6 months, recent major surgery or trauma, severe uncontrolled hypertension, thrombocytopenia and severe liver or kidney failure.

Sites / Locations

  • Department of Cardiology, Zhongshan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

placebo

reteplase 9mg

reteplase 18mg

Arm Description

intracoronary infusion with saline

intracoronary infusion with reteplase 9mg

intracoronary infusion with reteplase 18mg

Outcomes

Primary Outcome Measures

Myocardial infarct size
Myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI)

Secondary Outcome Measures

Amount of microvascular obstruction
The amount of microvascular obstruction (% of left ventricular mass) demonstrated by late gadolinium-enhanced MRI
ST-segment resolution
The percentage ST-segment resolution on an electrocardiogram
CKMB level
CKMB area under the curve (AUC)
Left ventricular ejection fraction
Left ventricular ejection fraction assessed by echocardiography
Incidence of major adverse cardiac events (MACE)
The composite of cardiac mortality, nonfatal myocardial reinfarction and target vessel revascularization
Myocardial Blush Grade
Angiographic measures of reperfusion. The score goes from 0 to 3, with 3 being normal and 0 being absence of myocardial blush
TIMI corrected frame count
Angiographic measures of reperfusion. Thrombolysis in myocardial infarction score with corrected frame count from angiogram to assess myocardial perfusion
TIMI flow grade
Angiographic measures of reperfusion. The score goes from 0 to 3, with 3 being normal and 0 being absence of coronary flow

Full Information

First Posted
September 19, 2020
Last Updated
September 13, 2023
Sponsor
Ge Junbo
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1. Study Identification

Unique Protocol Identification Number
NCT04571580
Brief Title
Effect of Low-dose Intracoronary Reteplase on Myocardial Infarct Size During Primary Percutaneous Coronary Intervention
Acronym
RECOVERII
Official Title
Effect of Low-dose Intracoronary Reteplase During Primary Percutaneous Coronary Intervention on Myocardial Infarct Size in Patients With Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
The study enrollment is slow due to the pandemic.
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ge Junbo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
OBJECTIVE: To determine whether a therapeutic strategy involving low-dose intracoronary fibrinolytic therapy with reteplase infused after coronary reperfusion will reduce the myocardial infarction size. DESIGN, SETTING, AND PARTICIPANTS: 306 patients presenting at 15 hospitals in China within 12 hours of acute ST-segment elevation myocardial infarction (STEMI) due to a proximal-mid-vessel occlusion of left anterior descending (LAD) coronary artery occlusion will be randomized in a 1:1:1 dose-ranging trial design. Patients will be followed up to 1 month. INTERVENTIONS: Participants will be randomly assigned to treatment with placebo (n = 102), reteplase 9mg (n = 102), or reteplase 18mg (n = 102) by manual infusion over 2 minutes after reperfusion of the infarct-related coronary artery and before stent implant. MAIN OUTCOMES AND MEASURES The primary outcomewas the myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI) conducted from days 2 through 7 after enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST-segment Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
intracoronary infusion with saline
Arm Title
reteplase 9mg
Arm Type
Experimental
Arm Description
intracoronary infusion with reteplase 9mg
Arm Title
reteplase 18mg
Arm Type
Experimental
Arm Description
intracoronary infusion with reteplase 18mg
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
intracoronary normal saline
Intervention Description
intracoronary infusion with normal saline
Intervention Type
Drug
Intervention Name(s)
Reteplase Injection 9mg
Other Intervention Name(s)
intracoronary reteplase 9mg
Intervention Description
low-dose intracoronary fibrinolytic therapy with reteplase 9mg
Intervention Type
Drug
Intervention Name(s)
Reteplase Injection 18mg
Other Intervention Name(s)
intracoronary reteplase 18mg
Intervention Description
low-dose intracoronary fibrinolytic therapy with reteplase 18mg
Primary Outcome Measure Information:
Title
Myocardial infarct size
Description
Myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI)
Time Frame
from days 2 through 7 after enrollment
Secondary Outcome Measure Information:
Title
Amount of microvascular obstruction
Description
The amount of microvascular obstruction (% of left ventricular mass) demonstrated by late gadolinium-enhanced MRI
Time Frame
from days 2 through 7 after enrollment
Title
ST-segment resolution
Description
The percentage ST-segment resolution on an electrocardiogram
Time Frame
60 minutes after reperfusion
Title
CKMB level
Description
CKMB area under the curve (AUC)
Time Frame
immediately before reperfusion (0 hours) and then again at 2 hours and at 24 hours
Title
Left ventricular ejection fraction
Description
Left ventricular ejection fraction assessed by echocardiography
Time Frame
1 and 30 days after PCI
Title
Incidence of major adverse cardiac events (MACE)
Description
The composite of cardiac mortality, nonfatal myocardial reinfarction and target vessel revascularization
Time Frame
30 days after PCI
Title
Myocardial Blush Grade
Description
Angiographic measures of reperfusion. The score goes from 0 to 3, with 3 being normal and 0 being absence of myocardial blush
Time Frame
0-1 hour at the end of PCI
Title
TIMI corrected frame count
Description
Angiographic measures of reperfusion. Thrombolysis in myocardial infarction score with corrected frame count from angiogram to assess myocardial perfusion
Time Frame
0-1 hour at the end of PCI
Title
TIMI flow grade
Description
Angiographic measures of reperfusion. The score goes from 0 to 3, with 3 being normal and 0 being absence of coronary flow
Time Frame
0-1 hour at the end of PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute STEMI with persistent ST-segment elevation or recent left bundle-branch block with a symptom onset to reperfusion time of 12 hours or less. Angiographic criteria included a proximal-mid coronary artery occlusion (TIMI coronary flow grade 0 or 1) or, impaired coronary flow (TIMI flow grade 2, slow but complete filling) in the presence of definite angiographic evidence of large thrombus (TIMI grade ≥2) in left anterior descending (LAD) coronary artery. Exclusion Criteria: Rescue PCI after thrombolytic therapy. Need for emergency coronary artery bypass grafting. Presence of cardiogenic shock. Life expectancy of < 6 months. Inability to provide informed consent. Contraindications for the use of thrombolysis, including active internal bleeding, history of intracranial haemorrhage or ischaemic stroke within 6 months, recent major surgery or trauma, severe uncontrolled hypertension, thrombocytopenia and severe liver or kidney failure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junbo Ge
Organizational Affiliation
Department of Cardiology, Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35800360
Citation
Huang D, Ma Y, Wu H, Zhong X, Gao W, Zhou J, Qian J, Ge J. Impact of intracoronary reteplase during primary percutaneous coronary intervention on infarct size in large anterior myocardial infarction: rationale and design of the RECOVER II trial. Cardiovasc Diagn Ther. 2022 Jun;12(3):352-359. doi: 10.21037/cdt-21-756.
Results Reference
result

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Effect of Low-dose Intracoronary Reteplase on Myocardial Infarct Size During Primary Percutaneous Coronary Intervention

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