Early Aggressive Versus Initially Conservative Therapy in Elderly Patients With Non-ST-Elevation Acute Coronary Syndrome
This study has been completed.
Sponsor:
Niguarda Hospital
Collaborator:
Italian Society of Cardiology
Information provided by (Responsible Party):
Niguarda Hospital
ClinicalTrials.gov Identifier:
NCT00510185
First received: July 31, 2007
Last updated: February 22, 2012
Last verified: February 2012
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Purpose
A randomized study comparing an early aggressive with an initially conservative strategy in patients >74 y.o. with non-ST-elevation acute coronary syndrome.
This study had generated a secondary one:
"Causes of death in elderly patients with Non-ST-Elevation Acute Coronary Syndrome; predictors of in-hospital and follow-up death"
| Condition | Intervention |
|---|---|
|
Acute Coronary Syndrome |
Other: systematic coronary intervention Other: coronary intervention only for cases refractory to medical therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Italian Elderly ACS Study |
Resource links provided by NLM:
Further study details as provided by Niguarda Hospital:
Primary Outcome Measures:
- The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within 1 yr. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- CV mortality at 1 yr; All-causes mortality, myocardial re/infarction 1 yr; Composite of death, myocardial re/infarction, disabling stroke, rehospitalization due to cardiovascular or clinically bleeding causes at 1 yr; Major bleeding, stroke at 1 yr [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 313 |
| Study Start Date: | October 2007 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Coronary angiography within 72h and revascularization as clinical indicated
|
Other: systematic coronary intervention
Coronary angiography within 72 hrs
|
|
No Intervention: 2
Initially conservative treatment with coronary angiography only for recurrent ischemia
|
Other: coronary intervention only for cases refractory to medical therapy
Initially conservative treatment with coronary angiography only for recurrent ischemia
|
Detailed Description:
Patients >74 y.o. with non-ST-elevation acute coronary syndrome will be randomised to an early aggressive (coronary angiography within 72 hours followed, when indicated, by revascularization) or an initially conservative strategy (medical therapy, and coronary angiography only for refractory ischemia).
As reported in Amendment 1, the trial was stopped in May 2010 after the enrolment of 313 patients, which was the minimum sample size calculated in order to achieve a 80% power of detecting a difference in the primary-endpoint rate from 40% in the conservative arm to 25% in the invasive arm, based upon the log-rank test for survival curves (1-beta 0.80; 2-tailed alpha 0.05)
Eligibility| Ages Eligible for Study: | 74 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Over 74 years of age.
- Have had symptoms suggestive of acute myocardial ischemia at rest within 48 hours prior to randomization, and ischemic ECG changes or elevated levels of biochemical markers of myocardial damage.
- Provide written informed consent before randomization.
Exclusion Criteria:
- Secondary causes of acute myocardial ischemia.
- Ongoing myocardial ischemia despite maximally titrated anti-ischemic therapy (invasive strategy recommended).
- Ongoing signs of acute heart failure despite treatment (invasive strategy recommended).
- Percutaneous coronary intervention or bypass surgery within 30 days prior to randomization.
- A serum creatinine level greater than 2.5 mg/dL.
- Active internal bleeding, history of hemorrhagic diathesis or recent transfusion of red blood cells, whole blood or platelets.
- History of cerebrovascular accident within the previous month.
- Known current platelet count < 90,000 cells/mL.
- Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
- Concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol.
- Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization.
- Inability to give at least verbal informed consent to the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510185
Locations
| Italy | |
| Dept. of Cardiology "A. De Gasperis" | |
| Milan, Italy, 20162 | |
Sponsors and Collaborators
Niguarda Hospital
Italian Society of Cardiology
Investigators
| Principal Investigator: | Stefano Savonitto, MD | Azienda Ospedaliera Ospedale Niguarda Ca' Granda-Dept. of Cardiology "A. De Gasperis" |
| Principal Investigator: | Stefano De Servi, MD | Dept. of Cardiology - Ospedale Civile di Legnano - Italy |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Niguarda Hospital |
| ClinicalTrials.gov Identifier: | NCT00510185 History of Changes |
| Other Study ID Numbers: | Italian Elderly ACS Study |
| Study First Received: | July 31, 2007 |
| Last Updated: | February 22, 2012 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Niguarda Hospital:
|
coronary artery disease coronary angioplasty coronary artery bypass surgery elderly |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013