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Clinical Study on Immediate Reversal of Heparin with the 301 Hospital Protamine Neutralization Regimen Following Percutaneous Coronary Intervention

Safety and effectiveness of immediate application of protamine to reverse heparin anticoagulation after PCI - a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125613
Enrollment
Unknown
Registered
2026-05-28
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Coronary heart disease

Interventions

Protamine group:If ACT is less than 150 seconds, no protamine is given
if 150 <= ACT < 200 seconds, (total dose of heparin (mg) / 2 - 10) mg of protamine is given
if 200 <= ACT < 250 seconds, (total dose of heparin (mg) / 2) mg of protamine is given
if 250 <= ACT < 300 seconds, (total dose of heparin (mg) / 2 + 10) mg of protamine is given
if ACT is greater than or equal to 300 seconds, (total dose of heparin (mg) / 2 + 20) mg of protamine is given
Control group:Heparin is naturally metabolized from the body

Sponsors

The Sixth Medical Center of the Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18, of either gender; 2. Both aspirin and ticagrelor were administered as premedication before surgery; 3. Patients with acute coronary syndrome (ACS), including unstable angina, non-ST segment elevation myocardial infarction, and ST segment elevation myocardial infarction; 4. For patients who are clinically diagnosed and require PCI treatment, the coronary intervention puncture sites include the radial artery, brachial artery, or femoral artery; 5. Use unfractionated heparin as an anticoagulant during the procedure; 6. The patient or their legal guardian signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals with severe allergy to heparin/protamine; 2. Moderate-to-severe pulmonary hypertension and moderate-to-severe heart valve disease; 3. Severe liver dysfunction (Child-Pugh Class C); 4. Severe renal dysfunction (most commonly defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2); 5. Preoperative active bleeding or abnormal coagulation function; 6. Platelet count <100×10^9/L; 7. Participate in other clinical trials that may affect the results of this study; 8. Refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Bleeding Complications;

Secondary

MeasureTime frame
Stent thrombosis and target lesion thrombosis;Protamine-related adverse events;Major cardiovascular events (MACE);

Countries

China

Contacts

Public ContactWang Qi

The Sixth Medical Center of the Chinese People's Liberation Army General Hospital

doctorwq301@163.com+86 158 1020 4279

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026