A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.Phase 4NCT01971606
Impact of High-dose Pretreatment of Rosuvastatin in Patients With Acute Coronary Syndrome Following Off-pump Coronary Artery Bypass: Results From the HIROP-ACS (HIgh-dose Pretreatment of Rosuvastatin During Off-Pump Coronary Bypass in Acute Coronary Syndrome) Study
A Phase 4 study testing Rosuvastatin in people with A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB., run by Yonsei University at 1 site in South Korea.
Trial summary
Periprocedural treatment with high-dose statins is known to have cardioprotective and pleiotropic effects, such as anti-thrombotic and anti-inflammatory actions. -Objective: to determine whether preoperative rosuvastatin loading is independently associated with reduced myocardial ischemia and clinical outcomes in… Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2007to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The presence of acute coronary syndrome, including unstable angina, acute non-ST elevation myocardial infarction
- Age of 19 years or older
- A need for isolated surgical myocardial revascularization
- Patients with signed informed consent
Who cannot join
- Patients with combined surgery with coronary bypass grafting
- On-pump conversion
- Patients with any increase in liver enzymes
- Patients with history of liver or muscle disease.
- Patients with moderate renal dysfunction (creatinine>2.0mg/dl) or need for dialysis
- Re-do surgery
- Urgent/emergent surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine
Seoul, 120-752
About this study
Periprocedural treatment with high-dose statins is known to have cardioprotective and pleiotropic effects, such as anti-thrombotic and anti-inflammatory actions.
-Objective: to determine whether preoperative rosuvastatin loading is independently associated with reduced myocardial ischemia and clinical outcomes in patients with stable angina undergoing isolated off-pump coronary bypass (OPCAB) in patients with acute coronary syndrome.
Read more
Study design
- Prospective, double-blinded, single-center study of each 117 subjects enrolled
- Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled preoperatively.
- Eligible subjects will be randomized 1:1 to A) High-dose rosuvastatin (n=117) vs. B) Placebo (n=117).
- The amount of preoperative administration of high-dose rosuvastatin will be 60mg of a total
- All subjects will undergo OPCAB procedure. - The primary and secondary endpoints will be compared at 30 days and 2 years postoperatively between two groups
- Being tested
- Rosuvastatin
- Keywords
- Statin, coronary artery bypass grafting, off-pump surgery, acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Patients will be randomized in a ratio of 1:1 to A) High-dose rosuvastatin vs. B) Placebo.
- Rosuvastatin group : Administration of 40mg of rosuvastatin PO 12 hours before surgery and 20mg of rosuvastatin PO 2hours before surgery and 10mg of rosuvastatin PO daily at postoperative period.
- Placebo group : Administration of placebo at 12 hours and 2 hours before surgery and 10mg of rosuvastatin PO daily at postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin group | Experimental | Rosuvastatin group Receives: Drug: Rosuvastatin |
| Placebo group | Placebo comparator | Placebo group Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACEs)
Major adverse cardiac events (MACEs), which include the following: death from all causes, non-fatal myocardial infarction (MI), and repeat revascularization by percutaneous intervention or bypass surgery within 30 days after OPCAB.
Measured: 30 days after OPCAB
Secondary outcomes (1)
The degree of myocardial ischemia and inflammatory
The degree of myocardial ischemia and inflammatory changes assessed by blood sampling and specific tests (CK-MB, Troponin T, ESR, CRP, hs-CRP) at the early period after OPCAB.
Measured: immediate, 24 hours, 48 hours, 72 hours, 7 days after OPCAB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startOct 2007
- Primary completionJun 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971606
- Sponsor's protocol ID
- 4-2007-0253
- Status last verified
- Oct 2013
- First submitted
- 23 Oct 2013
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patti G, Pasceri V, Colonna G, Miglionico M, Fischetti D, Sardella G, Montinaro A, Di Sciascio G. Atorvastatin pretreatment improves outcomes in patients with acute coronary syndromes undergoing early percutaneous coronary intervention: results of the ARMYDA-ACS randomized trial. J Am Coll Cardiol. 2007 Mar 27;49(12):1272-8. doi: 10.1016/j.jacc.2007.02.025.
PubMed 17394957
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High-dose Pretreatment of Rosuvastatin in Patients With Acute Coronary Syndrome Following Off-pump Coronary Artery Bypass: Results From the HIROP-ACS (HIgh-dose Pretreatment of Rosuvastatin During Off-Pump Coronary Bypass in Acute Coronary Syndrome) Study
- ClinicalTrials.gov ID
- NCT01971606
- Acronym / sponsor ID
- 4-2007-0253
- Keywords
- Statin, coronary artery bypass grafting, off-pump surgery, acute coronary syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Periprocedural treatment with high-dose statins is known to have cardioprotective and pleiotropic effects, such as anti-thrombotic and anti-inflammatory actions.
-Objective: to determine whether preoperative rosuvastatin loading is independently associated with reduced myocardial ischemia and clinical outcomes in patients with stable angina undergoing isolated off-pump coronary bypass (OPCAB) in patients with acute coronary syndrome.
Study design
- Prospective, double-blinded, single-center study of each 117 subjects enrolled
- Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled preoperatively.
- Eligible subjects will be randomized 1:1 to A) High-dose rosuvastatin (n=117) vs. B) Placebo (n=117).
- The amount of preoperative administration of high-dose rosuvastatin will be 60mg of a total
- All subjects will undergo OPCAB procedure. - The primary and secondary endpoints will be compared at 30 days and 2 years postoperatively between two groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin group | Experimental | Drug: RosuvastatinRosuvastatin group |
| Placebo group | Placebo comparator | Drug: RosuvastatinPlacebo group |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The presence of acute coronary syndrome, including unstable angina, acute non-ST elevation myocardial infarction
- Age of 19 years or older
- A need for isolated surgical myocardial revascularization
- Patients with signed informed consent
Key exclusion criteria (7 listed)
- Patients with combined surgery with coronary bypass grafting
- On-pump conversion
- Patients with any increase in liver enzymes
- Patients with history of liver or muscle disease.
- Patients with moderate renal dysfunction (creatinine>2.0mg/dl) or need for dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinPatients will be randomized in a ratio of 1:1 to A) High-dose rosuvastatin vs. B) Placebo. A) Rosuvastatin group : Administration of 40mg of rosuvastatin PO 12 hours before surgery and 20mg of rosuvastatin PO 2hours before surgery and 10mg of rosuvastatin PO daily at postoperative period. B) Placebo group : Administration of placebo at 12 hours and 2 hours before surgery and 10mg of rosuvastatin PO daily at postoperative period. | Drug | Placebo group, Rosuvastatin group |
Primary outcome
Major adverse cardiac events (MACEs)
Time frame: 30 days after OPCAB
Major adverse cardiac events (MACEs), which include the following: death from all causes, non-fatal myocardial infarction (MI), and repeat revascularization by percutaneous intervention or bypass surgery within 30 days after OPCAB.
1 secondary outcome
The degree of myocardial ischemia and inflammatory
Time frame: immediate, 24 hours, 48 hours, 72 hours, 7 days after OPCAB
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Background: PubMed 17394957Patti G, Pasceri V, Colonna G, Miglionico M, Fischetti D, Sardella G, Montinaro A, Di Sciascio G. Atorvastatin pretreatment improves outcomes in patients with acute coronary syndromes undergoing early percutaneous coronary intervention: results of the ARMYDA-ACS randomized trial. J Am Coll Cardiol. 2007 Mar 27;49(12):1272-8. doi: 10.1016/j.jacc.2007.02.025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB., run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACEs) (time frame: 30 days after OPCAB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.