The efficacy and safety of oral promidone in the treatment of acute ST segment elevation myocardial infarction

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500113389

Enrollment

Unknown

Registered

2025-11-27

Start date

2023-12-14

Completion date

Unknown

Last updated

2025-12-01

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

Conditions

ST-Segment Elevation Myocardial Infarction

Interventions

Promidone group:Administer 50mg/dose of promidone twice a day for a total of 90 days

Placebo group:Administer 50mg/dose of placebo twice a day for a total of 90 days

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: This study plans to include patients aged 18-80 who have experienced acute ST segment elevation myocardial infarction within 24 hours. The specific inclusion criteria are as follows: 1.Age 18-80 years old; 2.Acute myocardial infarction patients diagnosed clinically within 24 hours of onset plan to undergo emergency PCI; 3. Sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Severe heart failure; 2.Left ventricular ejection fraction<35%; 3.Stroke within the first 3 months; 4.Type 2 index myocardial infarction; 5.Inflammatory bowel disease or chronic diarrhea; 6. Neuromuscular disease or non transient creatine kinase levels exceeding three times the upper limit of the normal range (unless due to infarction); 7.Any known allergic reactions, hypersensitivity reactions, or contraindications to promidone; 8.Severe kidney disease with serum creatinine levels exceeding twice the upper limit of the normal range; 9. Severe liver disease; 10. Participate in other studies currently or within three months; 11.Pregnant and lactating women; 12.Tumor patients with an expected survival period of less than 1 year according to the study protocol; 13. Individuals with severe mental disorders who are unable to express their wishes; 14.Drug or alcohol abusers.

Design outcomes

Primary

Measure	Time frame
The incidence of major adverse cardiovascular events at 3-month follow-up, including cardiovascular death, cardiac arrest with resuscitation, myocardial infarction, stroke, and emergency hospitalization for coronary revascularization due to angina, as a composite endpoint.;	—

Secondary

Measure	Time frame
Postoperative ECG ST-segment resolution;Echocardiographic assessment: LVEF, LV, LA, IVS, LVPW, RV; presence of regional wall motion abnormalities; presence of myocardial infarction complications (ventricular septal rupture, papillary muscle dysfunction or rupture, cardiac rupture, ventricular aneurysm, embolism).;Laboratory biomarker assessment: NT-proBNP, CK, CK-MB, cTnI, SOD, MDA, LDL, CRP, IL-1ß, IL-6, IL-8, RIPK1/RIPK3/MLKL; reduction and normalization of NT-proBNP levels.;Incidence of MACEs at day 30 and day 90;	—

Measure

Time frame

Postoperative ECG ST-segment resolution;Echocardiographic assessment: LVEF, LV, LA, IVS, LVPW, RV; presence of regional wall motion abnormalities; presence of myocardial infarction complications (ventricular septal rupture, papillary muscle dysfunction or rupture, cardiac rupture, ventricular aneurysm, embolism).;Laboratory biomarker assessment: NT-proBNP, CK, CK-MB, cTnI, SOD, MDA, LDL, CRP, IL-1ß, IL-6, IL-8, RIPK1/RIPK3/MLKL; reduction and normalization of NT-proBNP levels.;Incidence of MACEs at day 30 and day 90;

—

Countries

China

Contacts

Public ContactLi Junming

Yichang Central People's Hospital

Lijunming@medmail.com.cn+86 138 7268 9727

Outcome results

None listed

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