Skip to content

A prospective randomized clinical trial, the effect of long acting CCBs in post-acute myocardial infarction patients

A prospective randomized clinical trial, the effect of long acting CCBs in post-acute myocardial infarction patients - ACROSS-AMI (ACh-induced Coronary Spasm Study - Nifedipine and Benidipine After Acute Myocardial Infarction)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010091
Enrollment
160
Registered
2013-02-21
Start date
2013-08-07
Completion date
Unknown
Last updated
2026-06-29

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(STEMI) or non-ST elevation myocardial infarction(NSTEMI)

Interventions

ACh-provocation test positive / Nifedipine arm ACh-provocation test positive / Benidipine arm ACh-provocation test negative / Control arm ACh-provocation test negative / Nifedipine arm ACh-provocation

Sponsors

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients that ACh-provocation test was performed within 2 weeks after hospitalization and no PCI-needed residual lesions were observed at discharge 2) Age: 20-85 years old 3) Patients that written informed consents were obtained

Exclusion criteria

Exclusion criteria: Patients with 1) Unstable angina (UAP) 2) Triple vessel disease 3) Left ventricular ejection fraction <40% 4) Chronic atrial fibrillation 5) Severe hepatic dysfunction 6) Low tolerability of DHP-CCB 7) A history of DES implantation 8) Patients who were recognized by the chief physician to be inappropriate for study participation

Design outcomes

Primary

MeasureTime frame
A rate of changes in ACh-provoked coronary constrictive response and degree of coronary vascular tone at the follow up CAG, 6-12 months after onset.

Secondary

MeasureTime frame
(1)Incidence of coronary spasm at the 2nd ACh-provocation test (2)Change in biomarkers (3)Cardiovascular events(cardiovascular death, non-fatal MI, UAP, rehospitalization for heart failure, re-PCI etc) (4)Adverse effects (5)Coronary lesion finding by OCT(if possible)

Countries

Japan

Contacts

Public ContactKoichi Kaikita

Graduate School of Medical Sciences, Kumamoto University Department of Cardiovascular Medicine

kaikitak@kumamoto-u.ac.jp096-373-5175

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026