ACRoss-AMI

JRCT ID: jRCTs071180056

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Acute Myocardial Infarction
• Date of first enrollment: 13/08/2013
• Target sample size: 130
• Study type: Interventional

Intervention(s)

After the treatments for the acute phase of myocardial Infarction,Ach-provocation test is performed for the patients that an agreement by a patient was provided.
The patients who are positive and negative for ACh-provocation test are included in examination 1 and 2, respectively.
The registration and assignment is performed using conditional assinment system in ACROSS-AMI office.

Examination 1: examination for the patients who are positive and for ACh-provocation test.
1. 50 patients treated with long-acting Nifedipine
2. 50 patients treated with Benidipine

Examination 2: examination for the patients who are negative and for ACh-provocation test.
1. 15 patients treated with long-acting Nifedipine
2. 15 patients treated with Benidipine

Patients are basically treated with 40mg/day of long-acting nifedipine (Maximam dose: 60mg/day) or with 4mg twice a day of benidipine,

Outcome(s)

• Primary Outcome: A rate of changes in ACh-provoked coronary constrictive response and degree of coronary vascular tone at the follow-up coronary angiogram at 6-12 months after primary PCI

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: 85age
• Gender: Both

Include criteria

The patients with ST elevation and non-ST elevation myocardial infarction underwent primary percutaneous coronary intervention (PCI) using the drug eluting stent (DES) or bare metal stent (BMS), who meets all the following eligibility criteria.
1 The patients who are performed ACh-provocation test at 2 weeks after admission and no residual organic stenosis needing PCI
2 Man and woman at the range from 20-85years old at the time of informed consent
3 The case that informed consent by a patient was provided in a document

Exclude criteria

1. Patient with unstable angina
2. Patients with triple vessel disease
3. Patients with left ventricular systolic dysfunction
(Ejection fraction <40%)
4. Patients with chronic atrial fibrillation
5. Patients with severe liver dysfunction
6. Patients who are intolerable with dihydropyridine based calcium channel blockers
7. Patients with prior PCI using DES8
8. Patients whom the chief physician judged to be inappropriate for study enrollment

Related Information

• Primary Sponsor: Kaikita Koichi
• Secondary Sponsor: Ishii Masanobu
• Source(s) of Monetary Support: Bayer Yakuhin, Ltd