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Prevention of Coronary Artery Spasm by Strong Statin, Open Label, Randomized Controlled Trial (PRINCESS trial)

Prevention of Coronary Artery Spasm by Strong Statin, Open Label, Randomized Controlled Trial (PRINCESS trial) - Prevention of Coronary Artery Spasm by Strong Statin(PRINCESS trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011026
Enrollment
80
Registered
2013-07-01
Start date
2013-07-01
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

Treatment with rosuvastatin 20mg once daily (Treatment begins from 5mg/day) Treatment with rosuvastatin 2.5mg once daily Dietetic treatment and therapeutic exercise

Sponsors

Showa University Fujigaoka Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with provoked coronary artery spasm. Boundary high LDL cholesterolemia. (100<=LDL-C<=139mg/dL) Patient who agreed with document.

Exclusion criteria

Exclusion criteria: Patients who take statin already. Patients with familial hypercholesterolemia or secondary hyperlipidemia. Serum TG is 400mg/dL or more. Patients who have hypersensitivity for statin. Patients who have active liver disease. Patients who have renal dysfunction. Serum CK is 500IU/L or more. Patients who take cyclosporine. Pregnancy or possibility of pregnancy. Patients who have hypothyroidism, inherited stripe disease (muscular dystrophy etc.) or the family medical histories and patients who have previous history of medicinal muscle disorder. Patient of drug abuse or alcoholism. Additionally, patients who do not receive physician's approval.

Design outcomes

Primary

MeasureTime frame
Comparison of incidence of provoked coronary artery spasm at 6-month follow-up between Rosuvastatin group and control group

Secondary

MeasureTime frame
Comparison of incidence of provoked coronary artery spasm at 6-month follow-up between Rosuvastatin high dose and low dose group and control group Relationship between lipid profiles and provoked coronary artery spasm rate Relationship between endothelial function and provoked coronary artery spasm rate Adverse events, side effect event

Countries

Japan

Contacts

Public ContactKohei Wakabayashi

Showa University Fujigaoka Hospital Division of Cardiology

kwaka@live.jp045-971-1151

Outcome results

None listed

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