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A Prospective, multicenter, rAndomized, placebo-coNtrolled, blind evaluated trial of the efficacy and safety of Adenosine in primary percutaneous Coronary intervention in patients with acute ST-sEgment elevation myocardial infArction: The PANACEA trial

A Prospective, multicenter, rAndomized, placebo-coNtrolled, blind evaluated trial of the efficacy and safety of Adenosine in primary percutaneous Coronary intervention in patients with acute ST-sEgment elevation myocardial infArction: The PANACEA trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073646
Enrollment
Unknown
Registered
2023-07-17
Start date
2023-07-24
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ST-sEgment elevation myocardial infArction

Interventions

treatment group:1ml of 100ug adenosine injection in 0.9% NaCl injection via suction catheter or micro-catheter in the distal part of the target lesion, followed by 2mg of adenosine injection, diluted
controp group:1ml of 0.9% NaCl injection was administered via a suction catheter or microcatheter in the distal segment of the target lesion by bullet injection, followed by a slow push of 10mL of 0.9

Sponsors

Zhongshan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. age 18-75 years, either sex; 2. onset to entry time = 6 hours; 3. 2 or more adjacent anterior leads with an elevated ST segment = 0.2 mV; 4. coronary angiography confirms that the offender vessel is an anterior descending branch with occlusion or sub-total occlusion (TIMI flow grade 0-1) and no severe stenosis (<50% stenosis) in the remaining vessels; 5. consent to emergency PCI and no contraindications to the treatment; 6. agree to be enrolled in the clinical study and follow-up, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. has received thrombolytic therapy; 2. has had a myocardial infarction or undergone revascularisation (PCI or CABG) within 6 months; 3. Severe bradyarrhythmias at presentation, e.g. atrioventricular block II-III, sick sinus node syndrome, history of prolonged Q-T interval, symptomatic persistent bradycardia (HR < 55 bpm) without pacemaker support; 4. previous history of bronchospasm or bronchial stenosis-related disease (e.g. chronic obstructive pulmonary disease, asthma, etc.); 5. patients with end-stage disease (e.g. advanced malignancy) and a life expectancy of less than 1 year; 6. women who are pregnant or breastfeeding; 7. patients who are allergic to adenosine injection or conventional medication; 8. patients who are participating in other interventional clinical studies or are considered by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Myocardial infarct size measured by cardiac magnetic resonance (CMR) 7 days after PCI;

Secondary

MeasureTime frame
Incidence of compound cardiovascular events include cardiovascular death, recurrent myocardial infarction, target vessel revascularisation and postoperative heart failure within 12 months after PCI;Proportion of complete ST-segment regression on ECG 90 minutes after PCI;TIMI blood flow frame count (cTFC) corrected immediately after PCI;Proportion of patients with MBG level 3 immediately after PCI;Proportion of no/slow flow in the immediate post-operative period after PCI;Peak cTnT, CK-MB and area under the curve at 6h, 12 and 24h after PCI;Serum NT-proBNP levels in 72 hours after PCI;Left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) measured by cardiac ultrasound 7 days after PCI;Percentage of myocardium at risk (AAR) measured by CMR 7 days after PCI;Myocardial salvage index (MSI) measured by CMR 7 days after PCI;Percentage of MVO at 7 days after PCI;

Countries

China

Contacts

Public ContactJunbo Ge

Zhongshan Hospital affiliated to Fudan University

ge.junbo@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026