Effect of Upstream Treatment With High Intensity Statin on the Outcomes of STMI Patients Treated With PPCI
NCT ID: NCT04754789
Last Updated: 2021-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
160 participants
INTERVENTIONAL
2021-02-20
2021-03-01
Brief Summary
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Detailed Description
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In addition to its beneficial lipid modulation effects, statins exert a variety of pleiotropic actions such as inflammatory inhibition, antiventricular remodeling, improving vascular endothelial function, and antioxidant effects. Because ofitsmultiple functions, atorvastatin therapy was associated with a significant reduction in cardiovascular morbidity and mortality both in primary and secondary prevention. The Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL)study demonstrated thatatorvastatin 80 mg which was given during the first days after an ACS decreased the rate of major adverse cardiovascular events (MACE). This effect was observed as early as 6 weeks after randomization and was significant at 16 weeks. Atorvastatin for Reduction of MYocardial Damage during Angioplasty (ARMYDA) trial demonstrated a reduction in peri-procedural myocardial infarction (MI) in patients with stable CAD undergoing PCI preloaded by high potency statins atorvastatin 80 mg. The ARMYDARECAPTURE study showed a reduction in 30 days MACE in patients with stable angina or with non-ST elevation MI who were previously treated with statins and were reloaded with high potency statins.
The prompt effect that was observed with high-potency statins is one of the cornerstones of the plaque stabilization hypothesis, in which a clinical effect is demonstrated well before the low levels of low density lipoprotein-cholesterol (LDL-c) can affect plaque progression.
The effect of high vs. low potency statins in ACS was examined by the Pravastatin or Atorvastatin. ThePCI PROVE IT, a sub-study of the PROVE IT-TIMI 22 trial, demonstrated that patients pretreated with high potency statins before PCI had a significantly lower rate of target vessel revascularization. TheIn-vitro models showed that statins given prior to PCI decrease distal embolization and increase circulating endothelial progenitor cells, thus potentially increase endothelial healing following the injury caused by PCI. In addition, patients undergoing elective PCI, which were pre-treated with statins, had less microcirculatory resistance compared to placebo.
Conversely, the STATIN STEMI Trial did not show a significant reduction of MACEs in patients preloaded with high-dose (80 mg) versus low-dose (10 mg) atorvastatin before primary PCI (5.8% versus 0.6%, p=0.26) but showed improved immediate coronary flow after primary PCI.
Furthermore, in the SECURE-PCI trial, the periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days in ACS patients.However, the subgroup analysis showed a significant reduction of MACE in STEMI patients preloaded with atorvastatin compared with the placebo (P=0.01), still not all patients were treated with primary PCI.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The inflammatory markers (TLC, NLR, CRP), TIMI flow (corrected TIMI frame count), Myocardial blush ST resolution at 90 min after PCI, Major adverse cardiovascular events (MACE) (in-hospital, 30 days, 3months), (Cardiac mortality, MI, HF, stroke, revascularization, stent thrombosis).
TREATMENT
SINGLE
Study Groups
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group for loading with statin before PPCI
All patients will receive the routine guidelines advised management before and after primary PCI.
Patients will be randomly assigned (1:1) to receive two 80-mg loading doses of atorvastatin, the first loading dose will be administered in the Emergency Room before transfer to Cath Lab, the second dose of 80-mg atorvastatin will be administered 24 hours afterthe first dose.
Atorvastatin
preloading with high dose statins (atorvastatin 80mg) with loading dose of dual antiplatelet( asprine 300 mg and ticagrelor 180 mg) pre-primary PCI
group receive the routine guidelines management before PPCI
All patients will receive the routine guidelines advised management before and after primary PCI.
Patients will be randomly assigned (1:1) to receive only the routine management.
Aspirin
Loading dose of dual antiplatelet (asprine 300 mg and ticagrelor 180 mg)
Interventions
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Atorvastatin
preloading with high dose statins (atorvastatin 80mg) with loading dose of dual antiplatelet( asprine 300 mg and ticagrelor 180 mg) pre-primary PCI
Aspirin
Loading dose of dual antiplatelet (asprine 300 mg and ticagrelor 180 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with contraindications to statins.
* Patients with cardiogenic shock.
* Patients with acute STEMI not eligible for Primary.
* Patients with other factors affecting leucocytic count such as active infection or leukemia.
* Inability to provide informed consent
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Monica Nabil Attalla
Principal investigator
Principal Investigators
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Central Contacts
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Other Identifiers
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High dose statin pre PPCI
Identifier Type: -
Identifier Source: org_study_id
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