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Prevention of myocardial injury with rosuvastatin during coronary intervention study

Prevention of myocardial injury with rosuvastatin during coronary intervention study - PRIMITIVE study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003265
Enrollment
400
Registered
2010-02-28
Start date
2008-09-01
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

Coronary Artery Disease

Interventions

Duration: from 5 - 10 days before PCI to the day of PCI Drug: rosuvastatin 2.5 mg Method: oral administration once a day Duration: from 5 - 10 days before PCI to the day of PCI Drug: rosuvastatin 1

Sponsors

Nippon Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with coronary aretery disease undergoing PCI 2. dyslipidemia (T-CHO=>220 mg/dl, TG=>150 mg/dl, HDL-CHO<40 mg/dl, or LDL-CHO=>100mg/dl, or already treated with statin) 3. Patients who agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with severe renal disease (sCR=>3.0, urine protein +++ urine OB +++) or liver disease (AST>100IU/l, ALT>100IU/l, T-bil>3.0mg/dl, PT<60%, albumin<2.8g/dl) 2. ACS patients who need to receive emergency revascularization 3. Patients with no-PCI indication lesion such as LMT 4. in-stent or para-stent restenosis 5. Patients who cannot take statin 6. malignancy

Design outcomes

Primary

MeasureTime frame
a) PCI related cardiac complication b) elevation of the following cardiac markers 1) troponin T 2) N-terminal pro brain natriuretic peptide 3) CPK, CPK-MB C) EKG change after PCI D) no reflow or slow flow after PCI

Secondary

MeasureTime frame
a) any adverse events related to rosuvastatin b) no reflow or slow reflow during PCI c) PCI related non-cardiac complication d) IVUS findings before PCI e) Cardiac events or death after 3-year follow-up period

Countries

Japan

Contacts

Public ContactHitoshi Takano

nippon Medical School Department of Medicine

htakano@nms.ac.jp0338222131

Outcome results

None listed

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