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AzTrials

Acute Coronary SyndromePhase 3NCT00251576

Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack (0733-180)

A Phase 3 study testing A-Phase: tirofiban; Z-Phase simvastatin, Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 years and Comparator: A-Phase: low molecular weight heparin, unfractionated heparin in people with Acute Coronary Syndrome, run by Organon and Co.

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

A-Phase: Evaluating patients with chest pain who are receiving approved drugs, to estimate the effectiveness of one type of blood thinner as compared to another type of blood thinner. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
A-Phase: tirofiban; Z-Phase simvastatin, Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 years and Comparator: A-Phase: low molecular weight heparin, unfractionated heparin
How many people
4,497 participants
Where
No sites listed yet
Study dates
1 Nov 1999to 23 Mar 2004
Phase
Phase 3
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A-Phase: Chest pain at rest for 10 minutes, EKG changes or elevated cardiac blood work
  • Z-Phase: elevated cholesterol , plus at least one risk factor ( > 70 years old, diabetes, history of prior heart or blood vessel disease, chest pain with EKG changes, elevation of cardiac lab work or positive cardiac tests , at least 2 heart vessels blocked [one >= 75% and one >= 50%])

Who cannot join

  • A-Phase: use of some specific cardiac drugs, high risk bleeding, prior blood clotting disorders
  • Z-Phase: elevation in certain cardiac blood tests, no significant heart damage at catheterization, planned cardiac surgery or specific cardiac drugs that lower cholesterol levels, within 6 weeks of enrollment

About this study

Official title: A Multicenter, Randomized, Controlled, Double-Blind Trial to Investigate the Clinical Efficacy and Tolerability of Early Treatment With Simvastatin 40 mg Daily for 30 Days, Followed by Simvastatin 80 mg Daily Thereafter in Tirofiban-Treated Acute Coronary Syndrome Patients Who Have Been Randomized to Receive Enoxaparin or Unfractionated Heparin in Conjunction With Aspirin

A-Phase: Evaluating patients with chest pain who are receiving approved drugs, to estimate the effectiveness of one type of blood thinner as compared to another type of blood thinner.

Z-Phase: To evaluate early treatment of patients with long term chest pain (using an approved drug for 30 days, followed by an increased dose of the drug) as compared to patients (treated with diet and 4 months placebo followed by diet and approved drug) in patients who have experienced acute chest pain or heart attack.

Being tested
A-Phase: tirofiban; Z-Phase simvastatin, Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 years, Comparator: A-Phase: low molecular weight heparin, unfractionated heparin, Duration of Treatment: A-Phase: low molecular weight heparin, 2 to 8 days; unfractionated heparin, minium suggested 48 hours, maximum 108 hours, Duration of Treatment: Z-Phase, 2 years.
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.

  • A-Phase: tirofiban; Z-Phase simvastatinDrug

  • Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 yearsDrug

  • Comparator: A-Phase: low molecular weight heparin, unfractionated heparinDrug

  • Duration of Treatment: A-Phase: low molecular weight heparin, 2 to 8 days; unfractionated heparin, minium suggested 48 hours, maximum 108 hoursDrug

  • Duration of Treatment: Z-Phase, 2 years.Drug

What is being measured

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

  1. Z-Phase: combined frequency of the following clinical endpoint events: cardiovascular death, MI, readmission for ACS.

Secondary outcomes (1)

  1. Z-Phase: the incidence of the following endpoints, evaluated individually and as a composite: cardiovascular death, MI, readmission for ACS, coronary revascularization due to documented ischemia and non-hemorrhagic stroke.

Timeline

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

  1. First posted10 Nov 2005 (estimated)
  2. Study start1 Nov 1999
  3. Primary completion23 Mar 2004
  4. Study completion23 Mar 2004

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4,497 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251576
Sponsor's protocol ID
0733-180
Other IDs
2005_101
Status last verified
Feb 2022
First submitted
9 Nov 2005
Last updated
15 Aug 2024
Results posted
No

Publications

  • de Lemos JA, Blazing MA, Wiviott SD, Brady WE, White HD, Fox KA, Palmisano J, Ramsey KE, Bilheimer DW, Lewis EF, Pfeffer M, Califf RM, Braunwald E; Investigators. Enoxaparin versus unfractionated heparin in patients treated with tirofiban, aspirin and an early conservative initial management strategy: results from the A phase of the A-to-Z trial. Eur Heart J. 2004 Oct;25(19):1688-94. doi: 10.1016/j.ehj.2004.06.028.

    PubMed 15451146

  • de Lemos JA, Blazing MA, Wiviott SD, Lewis EF, Fox KA, White HD, Rouleau JL, Pedersen TR, Gardner LH, Mukherjee R, Ramsey KE, Palmisano J, Bilheimer DW, Pfeffer MA, Califf RM, Braunwald E; Investigators. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA. 2004 Sep 15;292(11):1307-16. doi: 10.1001/jama.292.11.1307. Epub 2004 Aug 30.

    PubMed 15337732

  • Morrow DA, de Lemos JA, Sabatine MS, Wiviott SD, Blazing MA, Shui A, Rifai N, Califf RM, Braunwald E. Clinical relevance of C-reactive protein during follow-up of patients with acute coronary syndromes in the Aggrastat-to-Zocor Trial. Circulation. 2006 Jul 25;114(4):281-8. doi: 10.1161/CIRCULATIONAHA.106.628909. Epub 2006 Jul 17.

    PubMed 16847150

  • Wiviott SD, de Lemos JA, Cannon CP, Blazing M, Murphy SA, McCabe CH, Califf R, Braunwald E. A tale of two trials: a comparison of the post-acute coronary syndrome lipid-lowering trials A to Z and PROVE IT-TIMI 22. Circulation. 2006 Mar 21;113(11):1406-14. doi: 10.1161/CIRCULATIONAHA.105.586347. Epub 2006 Mar 13.

    PubMed 16534008

  • de Lemos JA, Wiviott SD, Murphy SA, Blazing MA, Lewis EF, Califf RM, Pfeffer MA, Braunwald E. Evaluation of the National Cholesterol Education Program Adult Treatment Panel III algorithm for selecting candidates for statin therapy: insights from the A to Z trial. Am J Cardiol. 2006 Sep 15;98(6):739-42. doi: 10.1016/j.amjcard.2006.03.060. Epub 2006 Jul 26.

    PubMed 16950174

  • Morrow DA, de Lemos JA, Blazing MA, Sabatine MS, Murphy SA, Jarolim P, White HD, Fox KA, Califf RM, Braunwald E; Investigators. Prognostic value of serial B-type natriuretic peptide testing during follow-up of patients with unstable coronary artery disease. JAMA. 2005 Dec 14;294(22):2866-71. doi: 10.1001/jama.294.22.2866.

    PubMed 16352794

  • Morrow DA, Wiviott SD, White HD, Nicolau JC, Bramucci E, Murphy SA, Bonaca MP, Ruff CT, Scirica BM, McCabe CH, Antman EM, Braunwald E. Effect of the novel thienopyridine prasugrel compared with clopidogrel on spontaneous and procedural myocardial infarction in the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis in Myocardial Infarction 38: an application of the classification system from the universal definition of myocardial infarction. Circulation. 2009 Jun 2;119(21):2758-64. doi: 10.1161/CIRCULATIONAHA.108.833665. Epub 2009 May 18.

    PubMed 19451347

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing A-Phase: tirofiban; Z-Phase simvastatin, Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 years and Comparator: A-Phase: low molecular weight heparin, unfractionated heparin in people with Acute Coronary Syndrome, run by Organon and Co.

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 2 inclusion and 2 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 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Z-Phase: combined frequency of the following clinical endpoint events: cardiovascular death, MI, readmission for ACS.. 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 NCT00251576, which also lists 7 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 15 Aug 2024.

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