Acute ST-segment Elevation Myocardial InfarctionPhase 3RECOVERIINCT04571580
Effect of Low-dose Intracoronary Reteplase on Myocardial Infarct Size During Primary Percutaneous Coronary Intervention
A Phase 3 study testing Normal Saline, Reteplase Injection 9mg and Reteplase Injection 18mg in people with Acute ST-segment Elevation Myocardial Infarction, run by Ge Junbo at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute ST-segment Elevation Myocardial Infarction
- What is being tested?
- Normal Saline, Reteplase Injection 9mg and Reteplase Injection 18mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Effect of Low-dose Intracoronary Reteplase During Primary Percutaneous Coronary Intervention on Myocardial Infarct Size in Patients With Acute Myocardial Infarction
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.
Read more
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.
- Being tested
- Normal Saline, Reteplase Injection 9mg, Reteplase Injection 18mg
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Also called intracoronary normal saline
intracoronary infusion with normal saline
Reteplase Injection 9mgDrug
Also called intracoronary reteplase 9mg
low-dose intracoronary fibrinolytic therapy with reteplase 9mg
Reteplase Injection 18mgDrug
Also called intracoronary reteplase 18mg
low-dose intracoronary fibrinolytic therapy with reteplase 18mg
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | intracoronary infusion with saline Receives: Drug: Normal Saline |
| reteplase 9mg | Experimental | intracoronary infusion with reteplase 9mg Receives: Drug: Reteplase Injection 9mg |
| reteplase 18mg | Experimental | intracoronary infusion with reteplase 18mg Receives: Drug: Reteplase Injection 18mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarct size
Myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI)
Measured: from days 2 through 7 after enrollment
Secondary outcomes (8)
Amount of microvascular obstruction
The amount of microvascular obstruction (% of left ventricular mass) demonstrated by late gadolinium-enhanced MRI
Measured: from days 2 through 7 after enrollment
ST-segment resolution
The percentage ST-segment resolution on an electrocardiogram
Measured: 60 minutes after reperfusion
CKMB level
CKMB area under the curve (AUC)
Measured: immediately before reperfusion (0 hours) and then again at 2 hours and at 24 hours
Left ventricular ejection fraction
Left ventricular ejection fraction assessed by echocardiography
Measured: 1 and 30 days after PCI
Incidence of major adverse cardiac events (MACE)
The composite of cardiac mortality, nonfatal myocardial reinfarction and target vessel revascularization
Measured: 30 days after PCI
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
Measured: 0-1 hour at the end of PCI
TIMI corrected frame count
Angiographic measures of reperfusion. Thrombolysis in myocardial infarction score with corrected frame count from angiogram to assess myocardial perfusion
Measured: 0-1 hour at the end of PCI
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
Measured: 0-1 hour at the end of PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Jul 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Why it stopped: The study enrollment is slow due to the pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ge Junbo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ge Junbo, Fudan University
- Investigators
- Junbo Ge, Principal investigator, Department of Cardiology, Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571580
- Sponsor's protocol ID
- RECOVERII
- Acronym
- RECOVERII
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2020
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35800360
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-dose Intracoronary Reteplase During Primary Percutaneous Coronary Intervention on Myocardial Infarct Size in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04571580
- Acronym / sponsor ID
- RECOVERII / RECOVERII
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study enrollment is slow due to the pandemic.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ge JunboUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Normal Salineintracoronary infusion with saline |
| reteplase 9mg | Experimental | Drug: Reteplase Injection 9mgintracoronary infusion with reteplase 9mg |
| reteplase 18mg | Experimental | Drug: Reteplase Injection 18mgintracoronary infusion with reteplase 18mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal SalineAlso: intracoronary normal salineintracoronary infusion with normal saline | Drug | placebo |
| Reteplase Injection 9mgAlso: intracoronary reteplase 9mglow-dose intracoronary fibrinolytic therapy with reteplase 9mg | Drug | reteplase 9mg |
| Reteplase Injection 18mgAlso: intracoronary reteplase 18mglow-dose intracoronary fibrinolytic therapy with reteplase 18mg | Drug | reteplase 18mg |
Primary outcome
Myocardial infarct size
Time frame: from days 2 through 7 after enrollment
Myocardial infarct size (% left ventricular mass) demonstrated by contrast-enhanced cardiac magnetic resonance imaging (MRI)
8 secondary outcomes
Amount of microvascular obstruction
Time frame: from days 2 through 7 after enrollment
ST-segment resolution
Time frame: 60 minutes after reperfusion
CKMB level
Time frame: immediately before reperfusion (0 hours) and then again at 2 hours and at 24 hours
Left ventricular ejection fraction
Time frame: 1 and 30 days after PCI
Incidence of major adverse cardiac events (MACE)
Time frame: 30 days after PCI
Myocardial Blush Grade
Time frame: 0-1 hour at the end of PCI
TIMI corrected frame count
Time frame: 0-1 hour at the end of PCI
TIMI flow grade
Time frame: 0-1 hour at the end of PCI
Results and safety
The study was stopped early (reason given: The study enrollment is slow due to the pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Results publication: PubMed 35800360Huang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge principal investigator
Department of Cardiology, Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Normal Saline, Reteplase Injection 9mg and Reteplase Injection 18mg in people with Acute ST-segment Elevation Myocardial Infarction, run by Ge Junbo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study enrollment is slow due to the pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarct size (time frame: from days 2 through 7 after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.