Comparison of Titanium-Nitride-Oxide Coated Bio-Active-Stent (Optimax™) to the Drug (Everolimus) -Eluting Stent (Synergy™) in Acute Coronary Syndrome

NCT02049229 | Unknown Phase 4 DMC

• 1 other identifier: SA-008
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of the prospective, randomized and a multicenter trial is to compare clinical outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus Synergy-EES. Second objective is to explore whether the Optimax-BAS use is superior compared with Synergy-EES use with respect of hard end points (cardiac death, MI and major bleeding).

Conditions

Myocardial Infarction; Percutaneous Coronary Intervention; Atherosclerosis

Keywords

Stent; Titanium; drug eluting stent; myocardial infarction; stent thrombosis

Outcome Measures

Primary Outcomes (2)

• MACE

  The primary end point (MACE) is the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR) during 12 months of follow-up (non-inferiority).

  12 months

• cardiac death, any myocardial infarction and major bleeding

  Co-Primary end point is the composite of during 18 months of follow-up (superiority).

  18 months

Secondary Outcomes (7)

• Composite of cardiac death, MI, stent thrombosis and TLR

  1, 6, 12 and 18 months, and at 2, 3, 4 and 5 years.

• Cardiac death or myocardial infarction

  Cardiac death or myocardial infarction

• Stent thrombosis

  Stent thrombosis

• All cause death

  All cause death

• TLR

  Target lesion revascularization

Study Arms (2)

OPTIMAX stent

EXPERIMENTAL

Patients randomised to receive titanium-nitride-oxide coated OPTIMAX-stent

Device: percutaneous coronary intervention

SYNERGY stent

ACTIVE COMPARATOR

Patients randomised to receive everolimus-eluting, biabsorabble polymer coated stent

Device: percutaneous coronary intervention

Interventions

percutaneous coronary intervention DEVICE

Optimax-stent implantation

Also known as: Titanium-nitride-oxide coated stent

OPTIMAX stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A) Patients presenting with non ST-elevation acute coronary syndrome:
• Ischemic symptoms suspected to represent a non-ST-elevation acute coronary syndrome (UAP / NSTE-MI) defined as:
• New onset of characteristic ischemic chest pain occurring at rest or within minimal exercise (lasting longer than 10 minutes) and planned to be managed with an invasive strategy, AND at least one of the following;
• ECG changes compatible with new ischemia (ST depression of at least 1mm or transient ST elevation or ST elevation of ≤ 1mm or T wave inversion greater than 2 mm in at least 2 contiguous leads).
• Already elevated troponin I or T above the upper limit of normal.
• Patients \> 60 years of age with normal ECG at admission are eligible provided there is a high degree of certainty that patient's presenting symptoms are due to myocardial ischemia. These patients must have documented evidence of previous coronary artery disease (CAD) with at least one of the following:
• Previous MI Previous PCI or CABG Positive exercise test Other evidence of CAD
• B) Patients presenting with ST-elevation myocardial infarction (STEMI)
• Ischemic symptoms suspected to represent ST-elevation myocardial infarction defined as:
• Patients presenting with sign or symptoms of acute MI and planned to be managed with an invasive strategy with intent to perform a PCI during the index hospitalization.
• ECG changes compatible with STEMI: persistent ST-elevation (\>2mm in two contiguous leads or \> 1mm in at least two limb leads), or new left bundle branch block, or Q-wave in two contiguous leads.
• II) Written informed consent

You may not qualify if:

• Age \< 18 years
• Expected survival \< 1 year
• Allergy to aspirin, clopidogrel, prasugrel or ticagrelol
• Allergy to heparins, glycoprotein IIb/IIIa inhibitors or bivalirudin
• Allergy to everolimus
• Active bleeding or significant increased risk of bleeding
• Stent length longer than 28 mm needed
• Stent diameter \> 4.0 mm needed
• Previous coronary artery bypass surgery (CABG)
• Aorto-ostial lesion
• Previous coronary stenting of the target vessel
• Thrombolysis therapy
• Cardiogenic shock
• Planned surgery within 12 months of PCI unless the dual antiplatelet therapy could be maintained throughout the perisurgical period

Sponsors & Collaborators

• The Hospital District of Satakunta: lead

Study Sites (6)

Heart Center, Helsinki University Hospital

Helsinki, Finland

RECRUITING

Kokkola Central Hospital

Kokkola, Finland

RECRUITING

Heart Center, Kuopio University Hospital

Kuopio, Finland

RECRUITING

Dep.Of Cardiology, Oulu University Hospital

Oulu, Finland

RECRUITING

Heart Center, Satakunta Central Hospital

Pori, 28500, Finland

RECRUITING

Heart Center, Turku University Hospital

Turku, 20100, Finland

RECRUITING

Related Publications (3)

• Bouisset F, Sia J, Mizukami T, Karjalainen PP, Tonino PAL, Pijls NHJ, Van der Heyden J, Romppanen H, Kervinen K, Airaksinen JKE, Lalmand J, Frambach P, Roza da Costa B, Collet C, De Bruyne B; TIDES-ACS Study Group. Titanium-Nitride-Oxide-Coated vs Everolimus-Eluting Stents in Acute Coronary Syndrome: 5-Year Clinical Outcomes of the TIDES-ACS Randomized Clinical Trial. JAMA Cardiol. 2023 Jul 1;8(7):703-708. doi: 10.1001/jamacardio.2023.1373.

  PMID: 37203243 DERIVED

• Tonino PAL, Pijls NHJ, Collet C, Nammas W, Van der Heyden J, Romppanen H, Kervinen K, Airaksinen JKE, Sia J, Lalmand J, Frambach P, Penaranda AS, De Bruyne B, Karjalainen PP; TIDES-ACS Study Group. Titanium-Nitride-Oxide-Coated Versus Everolimus-Eluting Stents in Acute Coronary Syndrome: The Randomized TIDES-ACS Trial. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1697-1705. doi: 10.1016/j.jcin.2020.04.021.

  PMID: 32703593 DERIVED

• Colkesen EB, Eefting FD, Rensing BJ, Suttorp MJ, Ten Berg JM, Karjalainen PP, Van Der Heyden JA. TIDES-ACS Trial: comparison of titanium-nitride-oxide coated bio-active-stent to the drug (everolimus)-eluting stent in acute coronary syndrome. Study design and objectives. Minerva Cardioangiol. 2015 Feb;63(1):21-9.

  PMID: 25670057 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Atherosclerosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Pasi P Karjalainen, MD, PhD, adj.Professor

CONTACT

+358 2 627 7500; pasi.karjalainen@satshp.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2019
• Last Updated: June 2, 2015

Record last verified: 2015-06

Locations

FI (6)