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Acute Myocardial InfarctionPhase 4OCTAVIANCT01377207

Optical Coherence Tomography Assessment of Gender diVersity In Primary Angioplasty. The OCTAVIA Trial

A Phase 4 study testing Primary PCI in people with Acute Myocardial Infarction, run by Italian Society of Invasive Cardiology at 14 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Recent studies suggest important gender differences in the pathophysiology and prognosis of ST-segment elevation myocardial infarction (STEMI). This is the first prospective controlled study to assess gender differences in the mechanism of plaque rupture/erosion and thrombus formation in patients presenting with STEMI… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Primary PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
14 sitesItaly
Study dates
Jan 2011to Apr 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute Myocardial MI with ST segment Elevation, within 6 hours from symptoms onset
  • Native coronary artery disease (no prior stent implant, no prior brachytherapy)
  • Signed patient informed consent

Who cannot join

  • Patients with left main disease
  • infarct lesions in bypass grafts
  • cardiogenic shock
  • renal failure
  • recent major bleeding
  • allergy to aspirin or clopidogrel
  • on anticoagulant therapy
  • no suitable anatomy for OCT (extreme tortuousity, very distal culprit lesion, and large infarct vessel > 4 mm in diameter)

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Italy14 sites

  • Ospedale Cardinal Massai

    Asti, AT, 14100

  • Ospedali Riuniti di Bergamo

    Bergamo, BG, 24124

  • Policlinico S.Orsola- Malpighi

    Bologna, BO

  • Ospedale Ferrarotto

    Catania, CT

  • Ospedale S. Anna

    Ferrara, FE, 44100

  • USL 9 Grosseto

    Grosseto, GR, 48100

  • Ospedale Civile

    Mirano, VE

  • Policlinico Padova

    Padova, PD

  • Policlinico Parma

    Parma, PR, 43126

  • Policlinico Gemelli

    Rome, Italy, 00168

  • Policlinico Le Scotte

    Siena, SI, 53100

  • Ospedale San Giovanni Bosco

    Torino, TO, 10154

  • Ospedale Le Molinette

    Torino, TO

  • Ospedale Mauriziano

    Torino, TO

Other trials in Italy

About this study

Recent studies suggest important gender differences in the pathophysiology and prognosis of ST-segment elevation myocardial infarction (STEMI). This is the first prospective controlled study to assess gender differences in the mechanism of plaque rupture/erosion and thrombus formation in patients presenting with STEMI treated with primary angioplasty. Gender-related mechanisms of plaque rupture or erosion will be investigated using a combination of Quantitative Coronary Angiography, high resolution Optical Coherence Tomography of the culprit vessel and histopathologic analyses of thrombus aspirates of the infarct related lesion, performed by independent core laboratories, blinded to group (male or female) and clinical variables.

Read the detailed description

In OCTAVIA; enrollment in a 1:1 ratio according to gender group will be ensured by a computer-assisted matching algorithm for gender and age (< 50, 51-70, and > 70 years). Matching has the purpose to enable enrollment of an even number of male and female patients in balanced age groups. This type of dynamic algorithm is appropriate when the composition of the referral population is not known in advance.

OCTAVIA will assess gender differences in the mechanism of plaque rupture. The study will also evaluate the changes in the vascular territory remote from the infarct related lesion, the local vascular response to primary angioplasty interventions and the correlation with clinical outcomes over one year of follow-up. These data are important to support a gender based differential strategy and can have a substantial impact for the improvement of clinical practice in the treatment of women with STEMI.

The study sample of 140 patients is sized to address the hypothesis that the female population has a lower prevalence of plaque rupture (primary endpoint) at baseline OCT than the male population. Computations were conducted assuming a prevalence of rupture of 82% in males and 60% in female patients (22% lower).

Confirmatory power calculation was performed on the basis of stent Strut Coverage at 9 month follow-up (co primary endpoint). Stent-strut coverage and apposition have been linked to the risk of stent thrombosis. However, our understanding of DES healing in male and female patients with ST-segment elevation myocardial infarction is restricted to post-mortem data. The investigators assumed a per patient stent strut coverage (a continuous variable with right skewed distribution) with mean of 97.0% and standard deviation of 4.0% in men, versus mean of 95.0% and standard deviation of 4.0% in women, following Xience Prime implantation. Thus, aiming for a 5% 2-tailed superiority alpha, an 80% power, and assuming a 1:1 enrollment according to gender, a total of 64 patients per group should be enrolled. Anticipating a 10% dropout rate due to patients lost to follow-up and inadequate imaging (included major side branch sections), the total enrollment is set at 70 patients per group (total population of 140 subjects).

Being tested
Primary PCI
Keywords
ST segment Elevation Myocardial Infarction, Optical Coherence Tomography, Percutaneous Coronary Intervention, Thrombus hystopathology, Gender differences
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Primary PCIProcedure or surgery

    Thrombus aspiration and hystopathological analysis, Optical Coherence Tomography assessment of STEMI culprit vessel, Primary PCI with Drug Eluting Stent implantation; Repeat OCT assessment of culprit vessel at 9 monts follow-up

Study groups in NCT01377207
Study groupRoleWhat they receive
Female ArmExperimentalFemale gender diagnosed with ST segment Elevation Myocardial Infarction (STEMI)
Receives: Procedure: Primary PCI
Male ArmActive comparatorMale Gender diagnosed with ST segment Elevation Acute Myocardial Infarction (STEMI)
Receives: Procedure: Primary PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of ruptured or eroded plaques at infarct related lesion as assessed by OCT before PCI

    To assess gender differences in the percentage of ruptured or eroded plaques at infarct related lesion as assessed by OCT. The OCT measurement is taken before stenting, when a TIMI flow 2-3 is detected. If baseline flow is TIMI 1, thrombus aspiration is performed before OCT.

    Measured: Plaque rupture is evaluated during the index PCI procedure.

  2. Percent of covered stent struts by OCT in infarct-related lesion at 9 months (co-primary endpoint).

    To assess gender differences in the percentage of covered stent struts at infarct related lesion as assessed by OCT performed in all patients at 9 months.

    Measured: Stent coverage is evaluated at 9 months by OCT performed in all patients.

Secondary outcomes (6)

  1. Minimal Fibrous Cap Thickness (MFCA) (µm) at infarct-related lesion as determined by OCT.

    To assess gender differences in Minimal Fibrous Cap Thickness at infart related lesion by OCT immediataly after reestablishment of TIMI (Thrombolysis In Myocardial Infarction) 2-3 coronary blood flow and before stent implantation.

    The evolution of fibrous cap thickness over time will be determined by OCT that will be performed in all patients at 9 months from the index procedure.

    Measured: MFCA at index procedure (immediately after reestablishment of TIMI 2-3 coronary flow by PCI) and at 9 months OCT performed in all patients.

  2. Presence and type of residual thrombus material in the culprit vessel.

    To assess gender differences in thrombus type by OCT in culprit vessel after reestablishment of TIMI (Thrombolysis In Myocardial Infarction) 2-3 coronary blood flow and before stent implantation.

    Measured: Residual thrombus in the infarct related vessel is evaluated during the index procedure: immediately after reestablishment of TIMI 2-3 coronary flow during primary percutaneous coronary intervention

  3. Number of TCFA (<65 µM) as assessed by OCT in the culprit vessel (infarct related).

    To assess gender difference in TCFA number as assessed by OCT in the infarct related vessel during the index procedure and at 9 months by OCT performed in all patients

    Measured: Thin Fibrous Cap Atheroma is assessed during the index procedure: immediately after reestablishment of TIMI 2-3 coronary flow before stent implantationduring PCI; and at 9 months by OCT performed in all patients.

  4. percent of malapposed-uncovered struts

    to assess gender difference in % malapposed/uncovered struts at 9 months follow up by OCT

    Measured: 9 months

  5. percent net volume obstruction

    To assess gender difference in % of stent volume obstruction by OCT at 9 months follow up

    Measured: 9 months

  6. percent abnormal intraluminal tissue

    To assess gender difference in % of abnormal intraluminal tissue by OCT at 9 months follow up

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2013
  4. Study completionApr 2013

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01377207
Sponsor's protocol ID
27/01/2011
Acronym
OCTAVIA
Status last verified
Apr 2013
First submitted
25 Jan 2011
Last updated
19 Apr 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Saia F, Komukai K, Capodanno D, Sirbu V, Musumeci G, Boccuzzi G, Tarantini G, Fineschi M, Tumminello G, Bernelli C, Niccoli G, Coccato M, Bordoni B, Bezerra H, Biondi-Zoccai G, Virmani R, Guagliumi G; OCTAVIA Investigators. Eroded Versus Ruptured Plaques at the Culprit Site of STEMI: In Vivo Pathophysiological Features and Response to Primary PCI. JACC Cardiovasc Imaging. 2015 May;8(5):566-575. doi: 10.1016/j.jcmg.2015.01.018. Epub 2015 Apr 15.

    PubMed 25890582

  • Guagliumi G, Capodanno D, Saia F, Musumeci G, Tarantini G, Garbo R, Tumminello G, Sirbu V, Coccato M, Fineschi M, Trani C, De Benedictis M, Limbruno U, De Luca L, Niccoli G, Bezerra H, Ladich E, Costa M, Biondi Zoccai G, Virmani R; OCTAVIA Trial Investigators. Mechanisms of atherothrombosis and vascular response to primary percutaneous coronary intervention in women versus men with acute myocardial infarction: results of the OCTAVIA study. JACC Cardiovasc Interv. 2014 Sep;7(9):958-68. doi: 10.1016/j.jcin.2014.05.011. Epub 2014 Aug 13.

    PubMed 25129664

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Primary PCI in people with Acute Myocardial Infarction, run by Italian Society of Invasive Cardiology at 14 sites in Italy.

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 3 inclusion and 8 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 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy. 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. 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?

Percentage of ruptured or eroded plaques at infarct related lesion as assessed by OCT before PCI (time frame: Plaque rupture is evaluated during the index PCI procedure.). The study lists 2 primary outcomes in all. 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 NCT01377207, which also lists 2 linked publications.

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 19 Apr 2013.

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